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Screening Women at High Genetic Risk for Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
cytology specimen collection procedure
annual screening
comparison of screening methods
Sponsored by
University College London Hospitals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Ovarian Cancer focused on measuring ovarian epithelial cancer

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Saint Bartholomew's Hospital
  • Institute of Child Health

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 9, 2002
Last Updated
December 17, 2013
Sponsor
University College London Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00033488
Brief Title
Screening Women at High Genetic Risk for Ovarian Cancer
Official Title
The UK Familial Ovarian Cancer Screening Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University College London Hospitals

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian epithelial cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
cytology specimen collection procedure
Intervention Type
Procedure
Intervention Name(s)
annual screening
Intervention Type
Procedure
Intervention Name(s)
comparison of screening methods

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Mackay, MD, MA, FRCP, FRCPE
Organizational Affiliation
Institute of Child Health
Official's Role
Study Chair
Facility Information:
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Institute of Child Health
City
London
State/Province
England
ZIP/Postal Code
WC1N 1EH
Country
United Kingdom

12. IPD Sharing Statement

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Screening Women at High Genetic Risk for Ovarian Cancer

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