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Ovarian Screening Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00267072
Recruitment Status : Completed
First Posted : December 20, 2005
Last Update Posted : January 9, 2018
James Graham Brown Cancer Center
Information provided by (Responsible Party):
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

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The University of Louisville Ovarian Screening Study
Study Start Date : June 2001
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00267072

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United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
James Graham Brown Cancer Center
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Principal Investigator: Cyril W. Helm, MD University of Louisville, James Graham Brown Cancer Center
1 Greenlee, R. T., M. B. Hill-Harmon, et al. (2001).

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Responsible Party: University of Louisville Identifier: NCT00267072    
Other Study ID Numbers: 328.01
First Posted: December 20, 2005    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Keywords provided by University of Louisville:
Ovarian Cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders