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

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ClinicalTrials.gov Identifier: NCT01292733
Recruitment Status : Terminated (Closed per local IRB due to advancements in standard ovarian cancer screening.)
First Posted : February 9, 2011
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Diseases Ovarian Neoplasms Other: Laboratory Tumor Marker Analysis Other: Transvaginal Ultrasound Other: Health Status Questionnaire Early Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 534 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Ovarian Cancer Early Detection Screening Program
Study Start Date : August 2009
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Measuring for elevated levels of tumor marker CA-125 in the blood over time. [ Time Frame: Average expected time of 1 year ]

Secondary Outcome Measures :
  1. Performing transvaginal ultrasounds to look for any abnormalities over time. [ Time Frame: Average expected time of 1 year ]
    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.

  2. Performing health status questionnaires over time [ Time Frame: Average expected time of 1 year ]

Eligibility Criteria

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292733

United States, Washington
Marsha Rivkin Center for Ovarian Cancer Research
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Swedish Medical Center
Fred Hutchinson Cancer Research Center
The Marsha Rivkin Center for Ovarian Cancer Research
Principal Investigator: Pamela Paley, MD Swedish Medical Center
More Information

Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT01292733     History of Changes
Other Study ID Numbers: IR 4707
CRC 08108 ( Other Identifier: Swedish Medical Center )
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

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
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders