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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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17,424 participants |
| Start Date | 2003-01-10 |
| Est. Completion | 2020-07-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00342953
The ClinicalTrials.gov registry entry for NCT00342953 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 17,424 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00342953 reports 0 study locations.
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.
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