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

Sponsor

Swedish Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT01292733

Collaborator

Fred Hutchinson Cancer Center (Other), The Marsha Rivkin Center for Ovarian Cancer Research (Other)

534

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

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

Actual Enrollment :

534 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Ovarian Cancer Early Detection Screening Program

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

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.

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

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

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.