Screening Women at High Genetic Risk for Ovarian Cancer

NCT00033488 | Completed

• 4 other identifiers: CDR0000069292UKFOCSSCRCA-FOCSEU-20044
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer. PURPOSE: Screening trial to determine the best procedure to detect ovarian cancer in women who have a high genetic risk for developing ovarian cancer.

Conditions

Ovarian Cancer

Keywords

ovarian epithelial cancer

Interventions

cytology specimen collection procedure OTHER

annual screening PROCEDURE

comparison of screening methods PROCEDURE

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * First-degree relative (mother, sister, or daughter) of an affected member of a high-risk family defined as one of the following: * Family containing 2 or more individuals with ovarian cancer who are connected by first-degree relationships * Family containing 1 individual with ovarian cancer and 1 individual with breast cancer and under 50 years of age at the time of diagnosis who are connected by first-degree relationships * Family containing 1 individual with ovarian cancer and 2 individuals with breast cancer and under 60 years of age at the time of diagnosis who are connected by first-degree relationships * Family containing an affected individual with a mutation of one of the known ovarian cancer predisposing genes * Family containing 3 individuals with colorectal cancer with at least 1 individual under 50 years of age at time of diagnosis and 1 individual with ovarian cancer who are connected by first-degree relationships * Families where affected relatives are related by second-degree relationships through an unaffected intervening male relative who has an affected daughter are allowed PATIENT CHARACTERISTICS: Age: * 35 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * No prior bilateral oophorectomy Other: * No concurrent participation in other ovarian cancer screening trials

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (2)

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Institute of Child Health

London, England, WC1N 1EH, United Kingdom

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• James Mackay, MD, MA, FRCP, FRCPE

  Institute of Child Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: SCREENING
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2000
• Study Completion: March 1, 2010
• Last Updated: December 18, 2013

Record last verified: 2007-06

Locations

GB (2)