Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00342953 · ClinicalTrials.gov registry record
Study of Health Effects of Cosmetic Breast Augmentation
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 17,424
- Enrollment target
NCT00342953: Completed study, sponsored by National Cancer Institute (NCI).
NCT00342953 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 17,424 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00342953 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 17,424 participants
- Enrollment target
Study Summary
This study will examine long-term health effects of cosmetic breast augmentation (enlargement) with silicone gel breast implants. There has been concern for some time about the possible effects of breast implants on the immune system particularly regarding the development of certain connective tissue disorders and on the possibility that implants may interfere with the ability to detect breast cancers. More recently, concerns have been raised regarding the possible cancer-causing effect of the implants themselves. These concerns were heightened by reports that the polyurethane foam coating that envelops the silicone gel in some implants may dissolve and produce a chemical called 2,4,-diamino toluene (TDA), which has been linked to an increased risk of breast and other cancers in rats and mice. To address this issue, this study will gather information from the medical records and a questionnaire survey of approximately 12,000 breast implant patients. The questionnaire will request information on perceived complications of the implants; history of breast examinations and mammograms; frequency of breast self examination; development of diseases (particularly cancers and connective tissue disorders) developed subsequent to the augmentation surgery; potential risk factors for these diseases, such as age at menarche (onset of menstruation), age at first birth, age and type of menopause (natural or due to surgery); history of breast biopsies; immune system and connective tissue disorders; cigarette smoking; alcohol consumption; family medical history, and so forth. To evaluate the results, the information will be compared with the same data on 4,000 women who underwent other plastic surgery procedures, such as rhinoplasty, facelift, liposuction, dermabrasion, eyelifts, and others, from the same practices as the breast augmentation patients. Participants will be recruited for the study from several large reconstructive and plastic surgery practices. Among the breast impla
Primary Outcome
Assessing effect of augmentative breast surgery upon breast cancer risk.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17,424 participants |
| Start Date | 2003-01-10 |
| Est. Completion | 2020-07-10 |
What the finished NCT00342953 record still lists
NCT00342953 is an observational study that tracks outcomes without assigning an intervention. Its 17,424 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT00342953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00342953 about?
NCT00342953 is a clinical study titled "Study of Health Effects of Cosmetic Breast Augmentation". This study will examine long-term health effects of cosmetic breast augmentation (enlargement) with silicone gel breast implants. There has been concern for some time about the possible effects of breast implants on the immune system particularly regarding the development of certain connective tissu...
What is the current status of trial NCT00342953?
This trial is currently completed. The enrollment target is 17,424 participants. The study started on 2003-01-10. Estimated completion is 2020-07-10.
Who is sponsoring clinical trial NCT00342953?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06272110 · 17,500 participants
Promoting Equitable Access to Language Services in Health and Human Services
- NCT07290361 · 17,587 participants · NA
Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT)
- NCT06245187 · 17,198 participants
Get With the Guidelines Atrial Fibrillation Registry
- NCT07108660 · 17,800 participants · NA
Machine Learning Prediction of Possible Central Line Associated Blood Stream Infections and Rate of Reduction
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI