Ovarian Cancer Early Detection Screening Program

Swedish Medical Center1 site in 1 country534 target enrollmentAugust 2009

ConditionsOvarian Diseases Ovarian Neoplasms

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Ovarian Diseases
Sponsor: Swedish Medical Center
Enrollment: 534
Locations: 1
Primary Endpoint: Measuring for elevated levels of tumor marker CA-125 in the blood over time.
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

December 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Swedish Medical Center

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Measuring for elevated levels of tumor marker CA-125 in the blood over time.

Time Frame: Average expected time of 1 year

Secondary Outcomes

Performing transvaginal ultrasounds to look for any abnormalities over time.(Average expected time of 1 year)
Performing health status questionnaires over time(Average expected time of 1 year)