Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer (OCEDP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Swedish Medical Center
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
The Marsha Rivkin Center for Ovarian Cancer Research
Information provided by (Responsible Party):
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT01292733
First received: November 30, 2010
Last updated: June 4, 2013
Last verified: June 2013

November 30, 2010
June 4, 2013
August 2009
August 2015   (final data collection date for primary outcome measure)
Measuring for elevated levels of tumor marker CA-125 in the blood over time. [ Time Frame: Average expected time of 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01292733 on ClinicalTrials.gov Archive Site
  • Performing transvaginal ultrasounds to look for any abnormalities over time. [ Time Frame: Average expected time of 1 year ] [ Designated as safety issue: No ]
    Criteria for an abnormal scan include 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. Volume calculations will determine whether the ovary is enlarged.
  • Performing health status questionnaires over time [ Time Frame: Average expected time of 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer
Ovarian Cancer Early Detection Screening Program

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.

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.

Interventional
Phase 0
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Ovarian Diseases
  • Ovarian Neoplasms
  • Other: 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.
  • Other: 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.
  • Other: Health Status Questionnaire
    Performed every 6 months, these questionnaires will ask about your health and medical history, environmental exposures, and family history.
Experimental: Ovarian Cancer Screening
CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires
Interventions:
  • Other: Laboratory Tumor Marker Analysis
  • Other: Transvaginal Ultrasound
  • Other: Health Status Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
August 2015
August 2015   (final data collection date for primary outcome measure)

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.
Female
30 Years and older
Yes
Contact: Paula Manner (206) 386-3788 paula.manner@swedish.org
Contact: Patra Grevstad, R.N., M.N. CancerResearch@swedish.org
United States
 
NCT01292733
IR 4707, CRC 08108
No
Swedish Medical Center
Swedish Medical Center
  • Fred Hutchinson Cancer Research Center
  • The Marsha Rivkin Center for Ovarian Cancer Research
Principal Investigator: Pamela Paley, MD Swedish Medical Center
Swedish Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP