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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
  Purpose

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

Condition
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The University of Louisville Ovarian Screening Study

Resource links provided by NLM:


Further study details as provided by James Graham Brown Cancer Center:

Estimated Enrollment: 5000
Study Start Date: June 2001
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

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
  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: NCT00267072

Locations
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Cyril W. Helm, MD University of Louisville, James Graham Brown Cancer Center
  More Information

No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00267072     History of Changes
Other Study ID Numbers: 328.01
Study First Received: December 19, 2005
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:
Ovarian 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 November 24, 2014