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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, ScreeningActive30 and overOtherIR 4707
CRC 08108, NCT01292733

Trial Description

Summary

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.

Further Study Information

The program will offer twice yearly CA-125 blood tests and annual transvaginal ultrasounds to monitor women at high risk for ovarian cancer. In addition to the main purpose of providing ovarian cancer screening, the researchers would also like to build a repository of blood specimens for use in ovarian and breast cancer research and to offer genetics counseling sessions to help educate women about risk-reducing options.

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Fred Hutchinson Cancer Research Center

The Marsha Rivkin Center for Ovarian Cancer Research

Pamela PaleyPrincipal Investigator

Paula MannerPh: (206) 386-3788
  Email: paula.manner@swedish.org

Trial Sites

U.S.A.
Washington
  Seattle
 Marsha Rivkin Center for Ovarian Cancer Research
 Paula Manner Ph: 206-386-3788
  Email: paula.manner@swedish.org
 Patra Grevstad, R.N., M.N.
  Email: CancerResearch@swedish.org
 Pamela PaleyPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01292733
Information obtained from ClinicalTrials.gov on May 15, 2012

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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