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

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer

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 Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

community sample

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: James Graham Brown Cancer Center
• Investigators: Principal Investigator: Cyril W. Helm, MD, University of Louisville, James Graham Brown Cancer Center

Publications and helpful links

General Publications

• Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001 Jan-Feb;51(1):15-36. doi: 10.3322/canjclin.51.1.15. Erratum In: CA Cancer J Clin 2001 Mar-Apr;51(2):144.

Study record dates

Study Major Dates

• Study Start: June 1, 2001
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: December 19, 2005
• First Submitted That Met QC Criteria: December 19, 2005
• First Posted (Estimate): December 20, 2005

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 5, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Ovarian Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms
• Other Study ID Numbers: 328.01