Screening Women at High Genetic Risk for Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

The UK Familial Ovarian Cancer Screening Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033488
• Other study ID #: CDR0000069292
• Secondary ID: UKFOCSSCRCA-FOCS
• Status: Completed
• Phase: N/A
• First received: April 9, 2002
• Last updated: December 17, 2013
• Start date: September 2000
• Est. completion date: March 2010

Study information

• Verified date: June 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Determine an optimal screening procedure for ovarian cancer, in terms of the most appropriate screening test, criteria for interpretation of results, and screening intervals, in women at high genetic risk for developing ovarian cancer.

• Determine the physical morbidity and the resource implications associated with ovarian cancer screening in these women.

• Assess the feasibility of screening this high-risk population in terms of compliance rates.

OUTLINE: Patients undergo transvaginal ultrasonography of the ovaries (scheduled for the early follicular phase, day 3-6 of the menstrual cycle) and CA 125 measurement annually. Blood samples are collected every 4 months for analysis of CA 125 levels and novel markers.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• cytology specimen collection procedure

Procedure:
• annual screening

• comparison of screening methods

Locations

Country	Name	City	State
United Kingdom	Institute of Child Health	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom,