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NCT00340600 · ClinicalTrials.gov registry record
Continuation of Follow-up of DES-Exposed Cohorts
A clinical trial of Breast Cancer and Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 10,805
- Enrollment target
- 1
- Study location
NCT00340600 is a study of Breast Cancer and Prostate Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 10,805 participants, above the 2,794-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (287% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00340600, a study of Breast Cancer and Prostate Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 10,805 participants
- Enrollment target
- 1
- Study location
Study Summary
Diethylstilbestrol (DES), a drug first synthesized in 1938, was administered to several million pregnant women in the U.S. and Europe for the prevention of spontaneous abortion and premature delivery. In 1971, Herbst reported a strong association between DES use in pregnancy and the occurrence of vaginal clear cell adenocarcinoma (CCA) in exposed female offspring. Animal models have demonstrated a range of DES effects on offspring exposed in utero, including reproductive dysfunction, immune system changes, behavioral and sexual abnormalities, and increases in various reproductive cancers in males and females. In the mid-1970's, several separate cohorts of DES-exposed daughters and unexposed comparison groups were followed for the occurrence of cancer, precursor lesions, and reproductive effects, but systematic follow-up of these cohorts had ceased by 1990. In 1992, Congress passed a bill (H;.R. 4178) mandating the continued follow-up of DES-exposed cohorts. The National Cancer Institute, in collaboration with five field centers, reassembled previously studied cohorts of DES-exposed and unexposed mothers, daughters and sons, and identified subjects with documented exposure status who had not been studied previously, through familial links within the cohorts. Standardized baseline questionnaires were mailed to cohort members to ascertain the risk of cancer and other disorders. Pathology reports were collected for reported cancers and preneoplastic conditions. Two separate rounds of follow up have been conducted and a third is almost complete. Patients from the Registry for Research on Hormonal Transplacental Carcinogenesis (the Registry) will be added to the follow-up effort in the third phase. The purpose of this study is to continue the follow-up, by means of mail questionnaires and medical record collection, which was begun during the first phase of the study. Concern has arisen that DES-exposed daughters may be at higher risk of breast cancer. Exposure to high lev
Conditions Studied
Study Locations (1)
Massachusetts
- Boston University School of Public Health - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,805 participants |
| Start Date | 1998-03-18 |
| Est. Completion | 2020-11-13 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00340600
The ClinicalTrials.gov registry entry for NCT00340600 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 10,805 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,794-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (287% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT00340600 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00340600 about?
NCT00340600 is a clinical study titled "Continuation of Follow-up of DES-Exposed Cohorts". Diethylstilbestrol (DES), a drug first synthesized in 1938, was administered to several million pregnant women in the U.S. and Europe for the prevention of spontaneous abortion and premature delivery. In 1971, Herbst reported a strong association between DES use in pregnancy and the occurrence of va...
What is the current status of trial NCT00340600?
This trial is currently completed. The enrollment target is 10,805 participants. The study started on 1998-03-18. Estimated completion is 2020-11-13.
What conditions does trial NCT00340600 study?
This clinical trial studies the following conditions: Breast Cancer, Prostate Cancer, Ovarian Cancer, Endometrial Cancer, Autoimmune Disease.
Who is sponsoring clinical trial NCT00340600?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00340600 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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