Screening Women at High Genetic Risk for Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00033488
First received: April 9, 2002
Last updated: December 17, 2013
Last verified: June 2007
  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: Primary Purpose: Screening
Official Title: The UK Familial Ovarian Cancer Screening Study

Resource links provided by NLM:


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

Estimated Enrollment: 5000
Study Start Date: September 2000
Study Completion Date: March 2010
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
Institute of Child Health
London, England, United Kingdom, WC1N 1EH
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Sponsors and Collaborators
University College London Hospitals
Investigators
Study Chair: James Mackay, MD, MA, FRCP, FRCPE Institute of Child Health
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00033488     History of Changes
Other Study ID Numbers: CDR0000069292, UKFOCSS, CRCA-FOCS, EU-20044
Study First Received: April 9, 2002
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014