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Sponsors and Collaborators: |
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00080639 |
RATIONALE: Measuring levels of CA 125 in blood samples of women who have a high risk of developing ovarian cancer may help doctors detect cancer early and plan more effective treatment.
PURPOSE: This phase II trial is studying CA-125 levels in screening for cancer in women who are at high risk of developing ovarian cancer.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer |
Procedure: physiologic testing Procedure: study of high risk factors |
Phase II |
Study Type: | Interventional |
Study Design: | Screening |
Official Title: | Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women |
Study Start Date: | June 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, pilot study.
Patients undergo blood collection and CA 125 levels are measured at baseline and then every 3 months for 1-2 years. Patients may be referred for an ovarian ultrasound if indicated by the CA 125 results.
Patients are followed at 6 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,400 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At high risk for developing ovarian cancer, as determined by meeting criteria for 1 of the following:
Family history of at least 2 ovarian or breast* cancers among the patient and first- and second-degree relatives within the same lineage**
Ashkenazi Jewish ethnicity and meets criteria for 1 of the following:
One first-degree or 2 second-degree relatives with breast* or ovarian cancer
Probability of BRCA1 or BRCA2 mutation greater than 20%, as determined by BRCAPRO 95% posterior probability interval
This criterion includes the following situations for which BRCAPRO is not required:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Alabama | |
Comprehensive Cancer Center at University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294-3300 |
Principal Investigator: | Edward E. Partridge, MD | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
Study ID Numbers: | CDR0000353332, UAB-120, UAB-0120 |
Study First Received: | April 7, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00080639 |
Health Authority: | United States: Federal Government |
ovarian epithelial cancer |
Genital Diseases, Female Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases |
Urogenital Neoplasms Endocrinopathy Ovarian Diseases Ovarian epithelial cancer Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |