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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: Completed study of Breast Cancer and Prostate Cancer, sponsored by National Cancer Institute (NCI).

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

primary outcome is cancer

Study Locations (1)

Massachusetts

  • Boston University School of Public Health - Boston

Trial Details

FieldValue
Enrollment Target 10,805 participants
Start Date 1998-03-18
Est. Completion 2020-11-13
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00340600 record still lists

NCT00340600 is an observational study that tracks outcomes without assigning an intervention. Its 10,805 participants enrollment target places it among the larger protocols in the corpus, above the 2,794-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (287% higher).

The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 0 interventions.

NCT00340600 reports a single indexed study location in 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.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00340600's enrollment target sits among peer trials

10,805 15th of 1224 higher than 1,210 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00340600, the US trial registry maintained by the National Library of Medicine. NCT00340600 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.