Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer
NCT ID: NCT01292733
Last Updated: 2016-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
534 participants
INTERVENTIONAL
2009-08-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Ovarian Cancer Screening
CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires
Laboratory Tumor Marker Analysis
Performed every 6 months, these blood samples will be drawn to measure the concentration of CA125 tumor marker. Remaining samples will be stored in a specimen repository for use in future research for ovarian and breast cancer tumor markers.
Transvaginal Ultrasound
Performed annually, these pelvic ultrasounds will be used used to look for 1) enlargement of one or both ovaries or 2) suspicious or indeterminate morphometric parameters, determined by the presence of intracystic papillations, and/or mural nodularity.
Health Status Questionnaire
Performed every 6 months, these questionnaires will ask about your health and medical history, environmental exposures, and family history.
Interventions
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Laboratory Tumor Marker Analysis
Performed every 6 months, these blood samples will be drawn to measure the concentration of CA125 tumor marker. Remaining samples will be stored in a specimen repository for use in future research for ovarian and breast cancer tumor markers.
Transvaginal Ultrasound
Performed annually, these pelvic ultrasounds will be used used to look for 1) enlargement of one or both ovaries or 2) suspicious or indeterminate morphometric parameters, determined by the presence of intracystic papillations, and/or mural nodularity.
Health Status Questionnaire
Performed every 6 months, these questionnaires will ask about your health and medical history, environmental exposures, and family history.
Eligibility Criteria
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Inclusion Criteria
* The family contains at least two ovarian or breast cancers in the subject or first or second degree relatives of the subject.
* The subject is of Ashkenazi Jewish ethnicity with one first degree or two second-degree relatives with breast or ovarian cancer, or subject is of Ashkenazi ancestry and has had breast cancer.
* The subject has a male relative with breast cancer diagnosed at any age.
* Probability of carrying a BRCA1/2 mutation given family pedigree of breast and ovarian cancers exceeds 20% (as determined by BRCAPRO 95% posterior probability interval).
Exclusion Criteria
* A first or second degree relative with a BRCA1/2 mutation and has tested negative for exactly the same mutation.
* The subject has no ovaries.
* Less than 30 years of age, unless 25-30 with BRCA I or II mutation confirmed
* Currently pregnant
* Currently receiving adjuvant chemotherapy or radiation therapy for cancer (excluding tamoxifen). Patients who are being treated for local disease may enroll 3 months after completion of last treatment (excluding tamoxifen).
* Treatment (excluding tamoxifen) for prior metastatic malignancy within the past five years.
* Intraperitoneal surgery within the last 3 months.
30 Years
FEMALE
Yes
Sponsors
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Fred Hutchinson Cancer Center
OTHER
The Marsha Rivkin Center for Ovarian Cancer Research
OTHER
Swedish Medical Center
OTHER
Responsible Party
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Principal Investigators
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Pamela Paley, MD
Role: PRINCIPAL_INVESTIGATOR
Swedish Medical Center
Locations
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Marsha Rivkin Center for Ovarian Cancer Research
Seattle, Washington, United States
Countries
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Related Links
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Marsha Rivkin Center for Ovarian Cancer Research
Other Identifiers
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CRC 08108
Identifier Type: OTHER
Identifier Source: secondary_id
IR 4707
Identifier Type: -
Identifier Source: org_study_id
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