Continuation of Follow-up of DES-Exposed Cohorts

NCT00340600 | Completed

• 2 other identifiers: 999998017OH98-C-N017
• Study Type: observational
• Target: 10,805
• Locations: 1 country
• Sites: 1

Brief 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 levels of endogenous estrogen in utero has been hypothesized to increase the risk of breast cancer and DES is a potent estrogen. Cancer risk in the sons will also continue to be assessed, especially for increased risks of prostate cancer. Since the offspring who were exposed to DES in utero are currently reaching their late forties, when cancer rates begin to rise, it is important to continue the follow-up of these cohorts to determine if there are long-term increases in cancer risk.

Conditions

Breast Cancer; Autoimmune Disease; Prostate Cancer; Ovarian Cancer; Endometrial Cancer

Keywords

Cancer; DES; Endocrine Disrupting Chemicals; In Utero

Outcome Measures

Primary Outcomes (1)

• Cancer

  primary outcome is cancer

  With Each Follow-up

Study Arms (2)

DES Exposed

DES-exposed mothers, daughters and sons, and identified subjects

DES Unexposed

DES-unexposed mothers, daughters and sons, and identified subjects

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

DES-exposed and unexposed mothers, daughters and sons, and identified subjects

You may qualify if:

• Exposed daughters and unexposed daughters originally identified at: Baylor College of Medicine, University of Southern California (USC), Gunderson Clinic, Mayo Clinic, and Massachusetts General Hospital (MGH).
• Male and female offspring of mothers who were enrolled in a clinical trial to assess the effectiveness of DES at the University of Chicago.
• Offspring of mothers who were treated with DES by an infertility specialist, Dr. Herbert Horne, in the Boston area.
• Offspring of DES-exposed mothers and unexposed mothers who were followed for breast cancer risk during the 1980s.
• Exposed sons and unexposed sons who were originally identified and followed at the Mayo Clinic during the late1970's for the occurrence of cancer, genital abnormalities and infertility.
• Subjects from the Registry for Research on Hormonal Transplacental Carcinogenesis.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Boston University School of Public Health

Boston, Massachusetts, 02118-2354, United States

Location

Related Publications (3)

• Robboy SJ, Noller KL, O'Brien P, Kaufman RH, Townsend D, Barnes AB, Gundersen J, Lawrence WD, Bergstrahl E, McGorray S, et al. Increased incidence of cervical and vaginal dysplasia in 3,980 diethylstilbestrol-exposed young women. Experience of the National Collaborative Diethylstilbestrol Adenosis Project. JAMA. 1984 Dec 7;252(21):2979-83.

  PMID: 6502858 BACKGROUND

• Labarthe D, Adam E, Noller KL, O'Brien PC, Robboy SJ, Tilley BC, Townsend D, Barnes AB, Kaufman RH, Decker DG, Fish CR, Herbst AL, Gundersen J, Kurland LT. Design and preliminary observations of National Cooperative Diethylstilbestrol Adenosis (DESAD) Project. Obstet Gynecol. 1978 Apr;51(4):453-8. doi: 10.1097/00006250-197804000-00014.

  PMID: 662228 BACKGROUND

• Herbst AL, Ulfelder H, Poskanzer DC. Adenocarcinoma of the vagina. Association of maternal stilbestrol therapy with tumor appearance in young women. N Engl J Med. 1971 Apr 22;284(15):878-81. doi: 10.1056/NEJM197104222841604. No abstract available.

  PMID: 5549830 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Autoimmune Diseases; Prostatic Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Study Officials

• Rebecca Troisi, D.Sc.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: March 18, 1998
• Primary Completion: September 30, 2015
• Study Completion: November 13, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

US (1)