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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 17, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Diseases
Ovarian Neoplasms
Other: Laboratory Tumor Marker Analysis
Other: Transvaginal Ultrasound
Other: Health Status Questionnaire
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Ovarian Cancer Early Detection Screening Program

Resource links provided by NLM:


Further study details as provided by Swedish Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 750
Study Start Date: August 2009
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ovarian Cancer Screening
CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires
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.

Detailed Description:

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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292733

Contacts
Contact: Paula Manner (206) 386-3788 paula.manner@swedish.org
Contact: Patra Grevstad, R.N., M.N. CancerResearch@swedish.org

Locations
United States, Washington
Marsha Rivkin Center for Ovarian Cancer Research Recruiting
Seattle, Washington, United States, 98122
Contact: Paula Manner    206-386-3788    paula.manner@swedish.org   
Contact: Patra Grevstad, R.N., M.N.       CancerResearch@swedish.org   
Principal Investigator: Pamela Paley, MD         
Sponsors and Collaborators
Swedish Medical Center
Fred Hutchinson Cancer Research Center
The Marsha Rivkin Center for Ovarian Cancer Research
Investigators
Principal Investigator: Pamela Paley, MD Swedish Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT01292733     History of Changes
Other Study ID Numbers: IR 4707, CRC 08108
Study First Received: November 30, 2010
Last Updated: September 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Swedish Medical Center:
Women with increased risk for developing ovarian cancer
Women diagnosed with reproductive cancer
Women with relatives who have had ovarian or breast cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Ovarian Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on October 02, 2014