Ovarian Screening Study

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT00267072
• Lead Sponsor: University of Louisville

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2001-06
• Study First Submitted: 2005-12-19
• Study First Submitted QC: 2005-12-19
• Study First Posted: 2005-12-20
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States