Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer
Conditions
Ovarian Diseases - Ovarian Neoplasms
Conditions: official terms
Ovarian Diseases - Ovarian Neoplasms
Conditions: Keywords
Women with increased risk for developing ovarian cancer, Women diagnosed with reproductive cancer, Women with relatives who have had ovarian or breast cancer
Study Type
Interventional
Study Phase
Phase 0
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: Laboratory Tumor Marker Analysis Type: Other
Name: Transvaginal Ultrasound Type: Other
Name: Health Status Questionnaire Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 30 Years
Gender: Female
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.
Location
Marsha Rivkin Center for Ovarian Cancer Research
Seattle, Washington, United States
Status: Recruiting
Contact: Paula Manner - 206-386-3788 - paula.manner@swedish.org
Start Date
August 2009
Completion Date
August 2017
Sponsors
Swedish Medical Center
Source
Swedish Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page