|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060028 / PAS001 |
| Date Original Protocol Accepted |
06/14/2013
|
| Date Current Protocol Accepted |
06/14/2013
|
| Study Name |
Post-Approval PMA Cohort Study (PACS)
|
| Device Name |
MENTOR MEMORYSHAPE BREAST IMPLANTS
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The MemoryShape Core Study is a post-approval cohort study to assess safety and effectiveness in augmentation, reconstruction, and revision (augmentation and reconstruction) patients. As part of the PMA conditions of approval, MemoryShape Core Study subjects will be expected to complete annual follow-up visits for safety and effectiveness through 10 years as well as MRI scans for all subjects at year 10.
|
| Study Population |
Women with Mentor¿s MemoryShape Breast Implants as indicated for primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction of the female breast.
|
| Sample Size |
A total of 955 subjects have been enrolled in MemoryShape Core Study. The protocol does not specify the number of clinical sites.
|
| Key Study Endpoints |
During the 10-year follow-up period, long-term safety of the Implants will continue to be measured by collecting the incidence, severity, method of resolution and duration for all complications (including device failures and adverse device effects) on a per-implant and per- patient basis. MRI scans to detect silent rupture of the implant for a subset of patients are at 1, 2,
4, 6, 8, and 10 years. Additionally, all patients are scheduled to receive MRI scans at year 6, 8 and 10. Safety assessments include complication rates, reasons for reoperation, and reasons for implant removal. Effectiveness assessments include bra cup size change (augmentation patients only), circumferential chest size change, measures of patients¿ satisfaction, and assessments of body image, self-esteem, and health related quality of life.
|
| Follow-up Visits and Length of Follow-up |
Subjects will be seen by the investigator in the investigator's office once a year until all subjects have reached 10-years post-implantation. In addition, all subjects in the study are scheduled to receive MRI scan at 10 years post-implantation.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
In total, 955 female subjects, including 572 primary augmentation, 124 revision-augmentation,
190 primary reconstruction, and 69 revision-reconstruction subjects, were enrolled.
Enrollment in the MRI Substudy included 252 primary augmentation, 56 revision-augmentation, 73 primary reconstruction, and 38 revision-reconstruction subjects.
|
| Actual Number of Sites Enrolled |
43
|
| Patient Follow-up Rate |
The follow-up rate at 10 years ranged from 60% to 74% across cohorts, with an overall follow-up rate of
63%. The cohort specific follow-up rates were as follows: 60% primary augmentation, 63% revision- augmentation, 67% primary reconstruction, and 74% revision-reconstruction.
The follow-up rates at 10 years for the MRI subset of subjects ranged from 42% to 57% across cohorts, with an overall follow-up rate of 45%. The cohort specific MRI Substudy follow-up rates were as follows:
44% primary augmentation, 44% revision-augmentation, 42% primary reconstruction, and 57% revision- reconstruction.
|
| Final Safety Findings |
The Kaplan-Meier estimated cumulative incidence rates at the subject level for the complications of any reoperation, explantation with or without replacement, explantation with replacement with study device, Baker III/IV capsular contracture, and infection are presented by cohort.
For the primary augmentation cohort, the KM estimated 10-year cumulative incidence rates were as follows: Baker Grade III/IV capsular contracture, 3.6%; infection, 0.7%; explantation with or without replacement, 9.2%; explantation with replacement with study device, 4.0%; and any reoperation, 22.3%.
For the revision-augmentation cohort, the KM estimated 10-year cumulative incidence rates were as follows: Baker Grade III/IV capsular contracture, 15.5%; infection, 1.9%; explantation with or without replacement, 25.9%; explantation with replacement with study device, 10.8%; and any reoperation, 35.0%.
For the primary reconstruction cohort, the KM estimated 10-year cumulative incidence rates were as follows: Baker Grade III/IV capsular contracture, 14.3%; infection, 1.6%; explantation with or without replacement, 34.1%; explantation with replacement with study device, 16.7%; and any reoperation, 52.7%.
For the revision-reconstruction cohort, the KM estimated 10-year cumulative incidence rates were as follows: Baker Grade III/IV capsular contracture, 16.4%; infection, 2.9%; explantation with or without replacement, 49.0%; explantation with replacement with study device, 27.9%; and any reoperation, 59.7%.
The Kaplan-Meier estimated cumulative incidence rates for rupture through 10 years for the MRI substudy subjects by cohort were: 6.6% primary augmentation, 9.6% revision- augmentation, 18.9% primary reconstruction, and 0% revision-reconstruction.
|
| Final Effect Findings |
For the primary augmentation cohort, the overall mean change in circumferential chest size through 10 years was 2.1 inches and statistically significant (p<0.0001), and the overall mean bra cup size increase from baseline across all follow-up visits was 2.2 cup sizes and statistically significant (p<0.0001). The primary effectiveness analysis was for the primary augmentation cohort only.
The percentage of subjects who answered the Global Subject Satisfaction question indicating they would make the same decision to have breast implant surgery was 96.9% at the Year 10 follow-up visit. The results were similar for the four subject cohorts: 96.6%, 95.5%, 100.0%, and 94.1% for the primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction cohorts, respectively.
|
| Study Strengths & Weaknesses |
One study strength is the 10-year prospective multi-center design to assess the long-term safety and
effectiveness of the device. The weaknesses of the study were the lack of a comparison group, and lack of statistical power to detect rare events due to the sample size.
|
| Recommendations for Labeling Changes |
Yes, the labeling will be updated based on the post-approval study results to provide patients and physicians with 10-year descriptive data on device performance.
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060028 / PAS002 |
| Date Original Protocol Accepted |
06/14/2013
|
| Date Current Protocol Accepted |
06/14/2013
|
| Study Name |
Post-approval Cont Access Study (PACAS)
|
| Device Name |
MENTOR MEMORYSHAPE BREAST IMPLANTS
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The Continued Access Study (CAS) was initiated to allow for continued physician experience with the device and to collect additional safety data. The PACAS is a post-approval continued access study designed to evaluate the safety of Mentor¿s MemoryShape Medium Height, Moderate Profile (CPG Style 321) Breast Implants in subjects previously enrolled in Mentor¿s CAS. Upon device approval, CPG CA study subject enrollment will be closed and the study will be converted to a post approval study for this style, i.e., CPG Style 321. The PACAS is to continue clinical follow-up of these patients with CPG Style 321 until each patient reaches her 5th year post-implantation. Subjects enrolled in the CA study with other CPG style breast implants will be followed under a new IDE protocol and study.
|
| Study Population |
Women with Mentor¿s MemoryShape Medium Height, Moderate Profile (CPG Style 321) Breast Implants as indicated for primary augmentation and revision augmentation of the female breast who were enrolled in the CAS but have not yet completed their 5-year follow-up.
|
| Sample Size |
A total of approximately 350 subjects who were enrolled in Mentor¿s Continued Access Study and implanted with MemoryShape Medium Height, Moderate Profile (CPG Style 321) for augmentation and reconstruction of the female breast and have not yet completed the 5-year study visit
|
| Key Study Endpoints |
During the 5-year follow-up period, safety of the implants will continue to be measured by collecting the incidence, severity, method of resolution and duration for all complications (including device failures and adverse device effects) on a per-implant and per-patient basis. Rheumatic Disease questionnaire will be employed at years 1, 2, 4 and 5. All PACAS subjects will be advised to see their surgeon if they believe they have a ruptured implant, and these subjects will undergo a Magnetic Resonance Imaging (MRI) scan.
|
| Follow-up Visits and Length of Follow-up |
Subjects will be seen by the investigator in the investigator's office once a year until all subjects have reached 5-years post-implantation. Follow-up study visits will take place at 10 weeks and then annually through 5 years after surgery.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
2,003
|
| Actual Number of Sites Enrolled |
62
|
| Patient Follow-up Rate |
62% at Year 5
|
| Final Safety Findings |
For the primary augmentation cohort, the KM estimated 5쳌year cumulative incidence rates for the key complications at the subject level were: Baker Grade III/IV capsular contracture, 0.7%; infection, 0.6%; explantation with or without replacement, 4.2%; explantation with replacement with study device,
1.1%; and any reoperation, 9.4%.
For the revision쳌augmentation cohort, the KM estimated 5쳌year cumulative incidence rates for the key complications at the subject level were: Baker Grade III/IV capsular contracture, 0.6%; infection, 1.4%; explantation with or without replacement, 8.7%; explantation with replacement with study device,
2.5%; and any reoperation, 17.9%.
For the primary reconstruction cohort, the KM estimated 5쳌year cumulative incidence rates for the key complications at the subject level were: Baker Grade III/IV capsular contracture, 5.3%; infection, 0.6%; explantation with or without replacement, 13.0%; explantation with replacement with study device,
7.6%; and any reoperation, 24.6%.
For the revision쳌reconstruction cohort, the KM estimated 5쳌year cumulative incidence rates for the key complications at the subject level were: Baker Grade III/IV capsular contracture, 9.8%; infection, 3.2%; explantation with or without replacement, 16.6%; explantation with replacement with study device,
6.0%; and any reoperation, 25.1%.
A total of 10 ruptures were reported, of which 9 were silent rupture.
|
| Final Effect Findings |
N/A
|
| Study Strengths & Weaknesses |
The Continued Access Study (CAS) was initiated to allow for continued physician experience with the device before device approval and to collect additional safety data. The Post쳌]approval Continued Access Study (PACAS) was designed to evaluate the safety of MemoryShape Medium Height, Moderate Profile (CPG Style 321) Breast Implants in subjects previously enrolled in the CAS. The overall patient follow쳌]up rate of the PACAS was 62% at Year 5. This follow쳌]up rate limited the interpretation of the available safety results.
|
| Recommendations for Labeling Changes |
No labeling change recommended at this time. The labeling has already contained 3쳌and 6쳌year data from the premarket cohort study and will be updated based on the 10쳌year clinical data from the Post쳌approval PMA Cohort Study for the same device.
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060028 / PAS005 |
| Date Original Protocol Accepted |
06/14/2013
|
| Date Current Protocol Accepted |
06/14/2013
|
| Study Name |
Focus Group Study
|
| Device Name |
MENTOR MEMORYSHAPE BREAST IMPLANTS
|
| General Study Protocol Parameters |
| Study Design |
Other Study Design
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of the Focus Group Study is to evaluate the patient informed decision brochure and ensure that the consumer information for Memory Shape Breast Implant meets patients and FDA¿s requirements.
The focus group will be conducted in person, rather than on the telephone with a moderator in the room.
|
| Study Population |
Women who have had breast reconstruction or breast augmentation or currently considering breast implant revision. At least 20% of participants should be non-Caucasian. For augmentation groups, at least 50% of participants must be between ages 25 to 35 years old.
|
| Sample Size |
Five in-person focus groups will be conducted (minimum eight respondents per conference): Augmentation
¿1 conference with women who have had breast augmentation
¿1 conference with women who have considered or are considering breast augmentation
Reconstruction
¿1 conference with women who have had breast reconstruction
¿1 conference with women who have considered or are considering breast reconstruction
Revision
¿1 conference with women who currently have breast implants and are considering or may have considered revision surgery to replace one or both of their implants
|
| Key Study Endpoints |
The study will employ two methods of data collection, focus groups and a self-administered survey, to capture both group-level and individual-level data.
A moderator will lead each group using discussion guide. Throughout the discussion, the moderator will pay attention to any unintended effects of the materials¿ content, particularly if respondents have any perceptions or beliefs that are inconsistent with the facts included in the patient educational material. Additionally, the moderator will probe for reactions to the sequencing of information, layout and format, and the effectiveness and clarity of data displays and other visual aids.
Respondents will also complete a self-administered survey designed to yield individual-level data on a number of critical questions. The survey will be designed to measure how well respondents¿ comprehended key information from the patient educational material, specifically what was learned in terms of the risks and benefits of receiving breast implants.
|
| Follow-up Visits and Length of Follow-up |
There is no follow-up in the Focus Group Study
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
33 (18 in the augmentation group and 15 in the reconstruction group)
|
| Actual Number of Sites Enrolled |
7
|
| Patient Follow-up Rate |
N/A
|
| Final Safety Findings |
Overall reactions to the patient educational materials are generally positive. Respondents in both the augmentation and reconstruction groups agree that the Patient Educational Brochure is relevant and clear. The study participants also offered suggestions for improving the materials.
|
| Study Strengths & Weaknesses |
The focus group study is quick, usually inexpensive, and useful in exploring ideas and concepts through group interaction. However, the analysis is qualitative, it is difficult to generalize results if small, unrepresentative samples of participants are used, and data analysis can be time consuming due to the open]ended nature of questions proposed for the focus group discussion.
|
| Recommendations for Labeling Changes |
No labeling change is recommended. The Focus Group Study was conducted to evaluate Patient Educational Brochures. No safety/effectiveness data of the sponsorfs approved device was collected in the study.
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P060028 / PAS003 |
| Date Original Protocol Accepted |
06/14/2013
|
| Date Current Protocol Accepted |
03/08/2022
|
| Study Name |
MemoryGel and Shape Glow Study
|
| Device Name |
MENTOR MEMORYSHAPE BREAST IMPLANTS
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
On August 30th -31st, 2011, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (link) met to discuss updates on the postmarket experience of silicone gel-filled breast implants and to make recommendations on issues related to the monitoring of silicone gel-filled breast implants. The Advisory Panel recommended more efficient approaches to assessing the performance of silicone gel-filled breast implants than continuing new enrollment in the large prospective studies. Their recommendations included conducting a systematic literature review and re-designing the Large Post-Approval Studies (PAS) to have more efficient methodologies to assess rare outcomes. In response, FDA entered a collaboration with the American Society of Plastic Surgeons (ASPS), the Plastic Surgeons Foundation (PSF), breast implant manufacturers and patient advocate groups, to establish the National Breast Implant Registry (NBIR) and the PROFILE Registry (established to collect data on potential cases of breast-implant anaplastic large cell lymphoma (BI-ALCL)). Tufts University was tasked with conducting a systematic literature review to look at rare endpoints and silicone gel-filled breast implants. Details on the literature review methodology and findings can be found here (Balk EM, et al., Long-Term Health Outcomes in Women With Silicone Gel Breast Implants: A Systematic Review. Ann Intern Med. 2016. 2;164(3):164-75).
The MemoryGel and Shape Glow Study was designed as part of the re-design of the Large PAS. This is a smaller cohort study (10 years follow-up) designed to address safety outcomes (i.e., including local complications, less rare connective tissue diseases, rheumatologic and neurologic signs and symptoms, breast cancer, lung cancer and suicide), reproduction and pregnancy outcomes, lactation problems, effects on mammography, effects on patient satisfaction with breasts and psychosocial wellbeing, and silicone subject compliance with magnetic resonance imaging (MRI) recommendations.
This restructured PAS, once completed as designed, would satisfy the post-approval requirements for both the MemoryGel® (P030053) and Memory Shape (P060028) silicone breast implants. In addition, information gained from the NBIR will help strengthen the general understanding of implantation rates and certain risks associated with breast implants.
|
| Study Population |
Women who receive Mentor?s MemoryGel and MemoryShape breast implants for the purpose of primary or revisional breast augmentation and primary or revisional breast construction. Additionally, women who undergo aesthetic surgery (for example liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty) will be enrolled as concurrent controls.
|
| Sample Size |
The study will enroll 3,500 women who received MemoryGel or MemoryShape Breast Implants, with a minimum of 750 subjects enrolled in each device family, and a concurrent control group of 300 women undergoing an aesthetic surgery other than breast implant surgery.
The study was designed to have 80% power to be able to detect as statistically significant a relative risk of 2.0 for adverse events that occur, without implants, with a frequency of 5.0 per 10,000 person-years, based on a one-sided test conducted at level of significance of 0.05. Based on these specifications, it was determined that approximately 20,328 person-years would be required.
Patients are to be followed for 10 years. For purposes of sample size calculation, assuming a follow-up rate of 65% at 10 years and a linear loss to follow-up, there would be an average of 8.075 person-years per patient. Thus, in order to obtain the 20,328 person-years, a total of at least 2,518 breast implant patients would be required.
|
| Key Study Endpoints |
Data on all study patients will be collected on the following safety endpoints: local complications, connective tissue disease (CTD), rheumatologic and neurologic signs and symptoms, cancer, suicide, and lactation complications. Magnetic resonance imaging (MRI) compliance and results will also be evaluated. Effectiveness will be assessed in a subset of breast implant patients by responses to questions addressing their perceived quality-of-life and satisfaction with their breast implants. Data for the concurrent control group patients will be collected for rheumatological and neurological signs and symptoms.
|
| Follow-up Visits and Length of Follow-up |
Prospective patients are considered enrolled in the study after completing the Informed Consent Form, baseline questionnaire, and surgery.
Enrollment in the MemoryShape group will include women who enroll prospectively, before undergoing their implant surgery, and women who enroll retrospectively, after having undergone their implant surgery.
At Years 1 to 10, online questionnaires are to be completed off-site by the breast implant patients. At Years 1, 5, and 10, the online BREAST-Q will be completed off-site by a subset of patients. Retrospectively enrolled patients will be required to complete follow-up questionnaires annually through the 10-year anniversary of the index surgery. All study patients will be seen by the investigator at any standard-of-care office visits and relevant adverse events will be captured in the study database.
At Years 1 to 10, online questionnaires are to be completed off-site by the concurrent control group patients.
Patients will be followed for 10 years.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
3,611
|
| Actual Number of Sites Enrolled |
62
|
| Patient Follow-up Rate |
The 2 year follow-up rates are:
82.6% - MemoryGel cohort
90.6% - MemoryShape Prospective cohort
83.3% - MemoryShape Retrospective cohort
76.6% - Control cohort
|
| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P060028 / PAS004 |
| Date Original Protocol Accepted |
06/14/2013
|
| Date Current Protocol Accepted |
06/14/2013
|
| Study Name |
Breast Implant Case-Control Studies
|
| Device Name |
MENTOR MEMORYSHAPE BREAST IMPLANTS
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent & Historical Control
|
| Analysis Type |
Analytical
|
| Detailed Study Protocol Parameters |
| Study Objectives |
On August 30th -31st, 2011, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (link) met to discuss updates on the postmarket experience of silicone gel-filled breast implants and to make recommendations on issues related to the monitoring of silicone gel-filled breast implants. The Advisory Panel recommended more efficient approaches to assessing the performance of silicone gel-filled breast implants than continuing new enrollment in the large prospective studies. Their recommendations included conducting a systematic literature review and re-designing the Large Post-Approval Studies (PAS) to have more efficient methodologies to assess rare outcomes. In response, FDA entered a collaboration with the American Society of Plastic Surgeons (ASPS), the Plastic Surgeons Foundation (PSF), breast implant manufacturers and patient advocate groups, to establish the National Breast Implant Registry (NBIR) and the PROFILE Registry (established to collect data on potential cases of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL)). Tufts University was tasked with conducting a systematic literature review to look at rare endpoints (listed below) and silicone gel-filled breast implants. Details on the literature review methodology and findings can be found here (Balk EM, et al., Long-Term Health Outcomes in Women With Silicone Gel Breast Implants: A Systematic Review. Ann Intern Med. 2016. 2;164(3):164-75).
The case-control study requirements originally were designed to study the following endpoints: rare connective tissue diseases, rare neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma. The PAS case-control study requirements were put on-hold while the systematic literature review was conducted. The systematic literature review showed insufficient evidence of association between silicone gel-filled breast implants and lymphoma, brain cancer, cervical cancer, rare connective tissue diseases (CTDs), or rare neurological events. Therefore, the PAS case-control studies were terminated because using case-control studies to evaluate these rare adverse events among patients with silicone breast implants would not provide additional value.
The FDA continues to monitor for these rare adverse events using other postmarket surveillance tools and real-world data (e.g. MDRs, NBIR, PROFILE).
|
| Study Population |
Women in Denmark, Germany, and the United Kingdom with the studied rare diseases (i.e., rare CTDs, rare neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma) as cases and women without any of the 5 studied rare diseases from the same countries as cases.
Inclusion criteria for cases:
¿Alive at the time of enrollment
¿Between 22 and 60 years of age at the time of enrollment
¿Identified with one of the ICD10 codes included in the protocol for the 5 studied diseases
¿Valid histological or staging information (for cases with brain cancer, cervical/vulvar cancer and lymphoma
Exclusion criteria for cases:
¿Women with a history of malignancy, connective tissue disease or neurological disease at the time of diagnosis
Women who either refuse to give permission to use their registry information, or do not live in the respective country or do not speak English, Danish or German, respectively
Inclusion criteria for the controls:
¿Between 22 and 60 years of age at the time of enrollment
¿Willing to provide the necessary information on their medical history (including the exposure to breast implants) and potential confounders
Exclusion criteria for cases:
¿Women who either refuse to give permission to use their registry information, or do not live in the respective country or do not speak English, Danish or German, respectively
¿Women with a history of any condition studied in the array of five case-control studies.
¿Women who provide unclear information that cannot be clarified by the interviewers
|
| Sample Size |
For each of the 5 case-control studies, 1,150 cases of women diagnosed with studied rare disease identified from the specialized medical centers and cancer registries in Denmark, Germany and the UK will be enrolled. A total of 5,000 females identified from the same neighborhood as cases without any of the 5 rare disease outcomes will be enrolled as a control group to the 5 case groups.
|
| Key Study Endpoints |
Data will be collected by using questionnaires as well as electronic information provided by the cancer registries/tumor centers. The same questionnaires will be used for cases and controls. The participating women will fill in the questionnaires on potential confounders (e.g., life-style related covariates) and exposure to breast implants. Similar questionnaires have been
successfully used in previous case-control studies with self-administered questionnaires.
The documented information will include:
-Country code
-Study site number
-Case/control ID number
-Date of birth
-Age at menarche
-History of pregnancies
-Regular menstrual bleeding
-Start of menopause
-History of breast implant
-Reason for breast implant (cosmetic, reconstruction, other)
-Names, types, and dates for breast implants
-Reasons for switch or stop of breast implant
-History of hormonal contraception
-History of hormone replacement therapy
-History of infection with HIV, Helicobacter pylori, or EBV
-Frequency of routine medical check-up in the decade before diagnosis of rare disease studied
-Number of lifetime x-rays, including computerized tomography
-Staging and histological information on lymphoma
-Date of lymphoma diagnosis
-History of other cancer
-History of other severe diseases
-History of treatment with immunosuppressive drugs
-Family history lymphoma
-Marital status
-Educational level achieved
-Professional exposure to radiation
-Postal code as proxy for size of town or city
-Body height
-Body weight
-Smoking status
-Alcohol consumption
-Level of physical exercise
-Date of completion of questionnaire
|
| Follow-up Visits and Length of Follow-up |
There is no follow-up for case-control studies.
|
