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| Sponsor: | University of Alabama at Birmingham |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00080639 |
Purpose
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 |
Other: physiologic testing Procedure: study of high risk factors |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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.
Eligibility| 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
Contacts and Locations| United States, Alabama | |
| Comprehensive Cancer Center at University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294-3300 | |
| Principal Investigator: | Edward E. Partridge, MD | University of Alabama at Birmingham |
More Information
| ClinicalTrials.gov Identifier: | NCT00080639 History of Changes |
| Other Study ID Numbers: | CDR0000353332, UAB-120, UAB-0120 |
| Study First Received: | April 7, 2004 |
| Last Updated: | May 30, 2009 |
| Health Authority: | United States: Federal Government |
|
ovarian epithelial cancer |
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |