Screening Women at High Genetic Risk for Ovarian Cancer - Full Text View

Sponsor:	University College London Hospitals
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00033488

Purpose

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.

Condition	Intervention
Ovarian Cancer	Other: cytology specimen collection procedure Procedure: annual screening Procedure: comparison of screening methods

Study Type:	Interventional
Study Design:	Screening
Official Title:	The UK Familial Ovarian Cancer Screening Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	5000
Study Start Date:	September 2000

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.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033488

Locations

United Kingdom, England
Institute of Child Health	Recruiting
London, England, United Kingdom, WC1N 1EH
Contact: James Mackay, MD, MA, FRCP, FRCPE 44-20-7679-8099 j.mackay@ich.ucl.ac.uk
Saint Bartholomew's Hospital	Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Ian Jacobs, MD 44-020-7601-8261

Sponsors and Collaborators

University College London Hospitals

Investigators

Study Chair:

James Mackay, MD, MA, FRCP, FRCPE

Institute of Child Health

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069292, UKFOCSS, CRCA-FOCS, EU-20044
Study First Received:	April 9, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00033488 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

ovarian epithelial cancer

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009