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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049049 |
RATIONALE: Surgery to remove the fallopian tubes and ovaries may decrease the risk of ovarian cancer and may improve quality of life in women who are at increased genetic risk. Monitoring CA 125 levels may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer.
PURPOSE: Screening trial to study the effectiveness of surgery to remove the fallopian tubes and ovaries combined with monitoring of CA 125 levels in participants who are at increased genetic risk for ovarian cancer.
Condition | Intervention |
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Ovarian Cancer |
Other: cancer prevention Other: physiologic testing Other: screening questionnaire administration Procedure: annual screening Procedure: comparison of screening methods Procedure: conventional surgery Procedure: evaluation of cancer risk factors Procedure: long-term screening Procedure: study of high risk factors |
Study Type: | Interventional |
Study Design: | Screening, Non-Randomized, Active Control |
Official Title: | Prospective Study of Prophylactic Salpingo-Oophorectomy and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer |
Estimated Enrollment: | 2332 |
Study Start Date: | April 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Participants choose 1 of 2 screening/prevention groups.
Participants then undergo risk-reducing salpingo-oophorectomy (RRSO). CA 125 is measured and ROCA calculated every 6 months. A mammogram is performed annually. Abnormal screening results are treated as in group I. Quality of life is assessed at baseline and at 6, 12, 24, and 60 months for some participants.
Participants in group I who decide to undergo RRSO may cross-over to group II at any time.
PROJECTED ACCRUAL: A total of 2,332 participants will be accrued for this study.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must meet 1 of the following criteria:
Documented deleterious BRCA1 or BRCA2 mutation in either participant or first- or second-degree* relative
Family contains at least 2 ovarian and/or breast cancers** among the participant or first- or second-degree* relatives within the same lineage
Participant is of Ashkenazi Jewish ethnicity with 1 first-degree* or 2 second-degree* relatives with breast and/or ovarian cancer***
NOTE: **Breast cancer in first- or second-degree male relatives is allowed
NOTE: ***For patients whose eligibility is based on the combination of Ashkenazi heritage, the Ashkenazi heritage must be on the same side of the family as are the breast and ovarian cancers
Ovarian cancer* in relatives may include any of the following:
Prior history of breast cancer is allowed and may include any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent participation in another ovarian cancer early detection trial except the Cancer Genetics Network's Risk of Ovarian Cancer Algorithm trial (if enrolled prior to entry into this study)
Study Chair: | Mark H. Greene, MD | Clinical Genetics Branch |
Study ID Numbers: | CDR0000257695, GOG-0199, NCI-02-C-0268 |
Study First Received: | November 12, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00049049 History of Changes |
Health Authority: | United States: Federal Government |
ovarian epithelial cancer |
Genital Diseases, Female Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Ovarian Cancer Endocrine System Diseases |
Urogenital Neoplasms Endocrinopathy Ovarian Diseases Ovarian Epithelial Cancer Endocrine Gland Neoplasms |
Genital Diseases, Female Neoplasms Neoplasms by Site Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases Endocrine Gland Neoplasms |