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

Swedish Medical Center

Status and phase

Terminated

Early Phase 1

Conditions

Ovarian Neoplasms

Ovarian Diseases

Treatments

Other: Transvaginal Ultrasound

Other: Laboratory Tumor Marker Analysis

Other: Health Status Questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT01292733

CRC 08108 (Other Identifier)

IR 4707

Details and patient eligibility

About

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.

Full 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.

Enrollment

534 patients

Sex

Female

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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.