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Ovarian Cancer Early Detection Screening Program

Phase 0
30 Years
Open (Enrolling)
Ovarian Diseases, Ovarian Neoplasms

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Trial Information

Ovarian Cancer Early Detection Screening Program

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.

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

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

- Intraperitoneal surgery within the last 3 months.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

Average expected time of 1 year

Safety Issue:


Principal Investigator

Pamela Paley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Swedish Medical Center


United States: Institutional Review Board

Study ID:

IR 4707



Start Date:

August 2009

Completion Date:

August 2015

Related Keywords:

  • Ovarian Diseases
  • Ovarian Neoplasms
  • Women with increased risk for developing ovarian cancer
  • Women diagnosed with reproductive cancer
  • Women with relatives who have had ovarian or breast cancer
  • Neoplasms
  • Ovarian Neoplasms
  • Ovarian Diseases



Marsha Rivkin Center for Ovarian Cancer Research Seattle, Washington  98122