Ovarian Screening Study

This study has been completed.
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00267072
First received: December 19, 2005
Last updated: April 22, 2013
Last verified: April 2013

December 19, 2005
April 22, 2013
June 2001
May 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00267072 on ClinicalTrials.gov Archive Site
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Ovarian Screening Study
The University of Louisville Ovarian Screening Study

The objectives of this study are:

  • To identify women at increased risk for developing ovarian cancer
  • To detect ovarian cancers at an early stage
  • To investigate the role of tumor membrane fragments as tumor markers for early ovarian carcinoma

In the year 2001 approximately 23,400 women in the USA are expected to be diagnosed with ovarian carcinoma and 13,900 will die of the disease. This means that within the USA more women die annually from ovarian cancer than all other gynecologic malignancies combined. Within the Commonwealth of Kentucky approximately 250 women per year develop ovarian carcinoma.

Survival for patients with ovarian cancer is directly related to the stage of disease at diagnosis. Unfortunately, the majority of women present with advanced disease (Stage III and IV) and most of these patients will die of the disease.

The aim of screening for ovarian cancer is to reduce the morbidity and mortality by detecting the disease at an early stage since ovarian cancer detected when disease is confined to the ovary (Stage I) is associated with a dramatically improved 5-year survival. Disease confined to the ovary may be cured in over 90% of patients, in some cases without the need for chemotherapy.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

community sample

Ovarian Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5000
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Asymptomatic women over the age of 45 with one or both ovaries.
  • Women over the age of 25 with one or both ovaries and any of the following:

    • A personal history of breast, colon or endometrial cancer or breast cancer gene (BRCA) 1 or 2 positive
    • First-degree relative (mother, sister, daughter) with ovarian or breast cancer
    • Two family members with either breast and/or ovarian cancer
    • Mother, sister, daughter, grandparent with a positive BRCA1 or BRCA2 genetic test result.
    • Past use of fertility drugs such as Clomid or Pergonal for more than a year.

Exclusion Criteria:

  • Women who are symptomatic of ovarian cancer
Female
25 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00267072
328.01
Yes
James Graham Brown Cancer Center
James Graham Brown Cancer Center
University of Louisville
Principal Investigator: Cyril W. Helm, MD University of Louisville, James Graham Brown Cancer Center
James Graham Brown Cancer Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP