- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00342953
Study of Health Effects of Cosmetic Breast Augmentation
Extended Mortality Follow-Up of Women With Augmentation Mammoplasty
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 implant patients, women who have had bilateral breast implants for cosmetic purposes only, and not as breast reconstruction after breast cancer surgery, will be eligible. Women with a history of breast cancer may not participate.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Maryland
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Bethesda, Maryland, États-Unis, 20892
- National Cancer Institute (NCI), 9000 Rockville Pike
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
- INCLUSION AND EXCLUSION CRITERIA:
The following criteria for inclusion in the study cohort will apply:
- Age. No age restrictions apply; patients receiving cosmetic implants at any age will be eligible for study.
- Cosmetic augmentation only. Patients with breast reduction surgery or reconstructive surgery following breast cancer will not be included.
- Females only. Implants in conjunction with sex change surgery will not be included.
- Bilateral implants only. Patients with unilateral implants will not be included.
- First occurrence of a breast implant. Patients with a previous breast implant will not be included.
- Patients with a history of plastic surgery involving silicone exposure will not be included.
- Patients with a history of breast cancer at or before the time of implant will not be included.
- Patients residing in defined geographic areas at the time that their plastic surgery was sought (these areas will need to be individually defined for each study site).
- Patients with a history of breast surgery for non-cancerous events, those with a history of cancer of sites other than the breast, and those with documented histories of connective tissue disorders will continue to be eligible for cohort inclusion, although information on these conditions will be abstracted so that separate analyses can be pursued.
For the comparison cohort, items a, c, f, g, h and i will apply. Patients currently receiving an operation involving implantation of silicon will not be included in the comparison cohort.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Cohort
Women receiving implants and other plastic surgery.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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No intervention
Délai: Indefinite
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Assessing effect of augmentative breast surgery upon breast cancer risk.
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Indefinite
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Robert N Hoover, M.D., National Cancer Institute (NCI)
Publications et liens utiles
Publications générales
- Baldwin CM Jr, Kaplan EN. Silicone-induced human adjuvant disease? Ann Plast Surg. 1983 Apr;10(4):270-3. doi: 10.1097/00000637-198304000-00002.
- Benavent WJ. Treatment of bilateral breast carcinomas in a patient with silicone-gel breast implants. Case report. Plast Reconstr Surg. 1973 May;51(5):588-9. doi: 10.1097/00006534-197305000-00026. No abstract available.
- Ashley FL. A new type of breast prosthesis. Preliminary report. Plast Reconstr Surg. 1970 May;45(5):421-4. doi: 10.1097/00006534-197005000-00001. No abstract available.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 999903082
- 03-C-N082
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Essais cliniques sur Cancer du sein
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AstraZenecaRecrutementAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian CancerEspagne, États-Unis, Belgique, Royaume-Uni, France, Hongrie, Canada, Corée, République de, Australie