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Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer

Sponsored by Swedish Medical Center

Phase Quota
Phase 0

The main purpose of this program is to see whether periodically measuring CA-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer.

Study Start Date: August 2009

Estimated Completion Date: December 2015

Specialties: Obstetrics & Gynecology: Gynecologic Oncology Oncology: Gynecologic Oncology Radiology: Ultrasound Physician Assistant: Hematology/Oncology,Obstetrics/Gynecology,Radiology

Interventions

  • Other: Transvaginal Ultrasound
  • Other: Health Status Questionnaire
  • Other: Laboratory Tumor Marker Analysis

Inclusion criteria

  • Must meet one of the following:
  • 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

  • Prior ovarian cancer or peritoneal carcinomatosis
  • 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

Study Locations And Contact Information

  • Marsha Rivkin Center for Ovarian Cancer Research, Seattle Washington
  • Marsha Rivkin Center for Ovarian Cancer Research, Seattle Washington

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