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

Early Phase 1

Terminated

• Conditions: Ovarian Neoplasms; Ovarian Diseases
• Interventions: Other: Laboratory Tumor Marker Analysis; Other: Transvaginal Ultrasound; Other: Health Status Questionnaire

• Registration Number: NCT01292733
• Lead Sponsor: Swedish Medical Center

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.

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 Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2011-02-08
• Study First Posted: 2011-02-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-15
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 534

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ovarian Cancer Screening	Transvaginal Ultrasound	CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires
Ovarian Cancer Screening	Laboratory Tumor Marker Analysis	CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires
Ovarian Cancer Screening	Health Status Questionnaire	CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires

Primary Outcome Measures

Name	Time	Method
Measuring for elevated levels of tumor marker CA-125 in the blood over time.	Average expected time of 1 year

Secondary Outcome Measures

Name	Time	Method
Performing transvaginal ultrasounds to look for any abnormalities over time.	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.
Performing health status questionnaires over time	Average expected time of 1 year

Trial Locations

Locations (1)

Marsha Rivkin Center for Ovarian Cancer Research; 🇺🇸 Seattle, Washington, United States