Clinical trial NCT01292733: Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer
Official title: Ovarian Cancer Early Detection Screening Program
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Ovarian Diseases
Ovarian Neoplasms
Keywords: Women with increased risk for developing ovarian cancer
Women diagnosed with reproductive cancer
Women with relatives who have had ovarian or breast cancer
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
Collaborators: name: Fred Hutchinson Cancer Center
name: The Marsha Rivkin Center for Ovarian Cancer Research
First posted: 2011-02-09
Enrollment: 534
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Measuring for elevated levels of tumor marker CA-125 in the blood over time.
timeFrame: Average expected time of 1 year
Secondary outcomes:
measure: Performing transvaginal ultrasounds to look for any abnormalities over time.
timeFrame: Average expected time of 1 year
measure: Performing health status questionnaires over time
timeFrame: Average expected time of 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Marsha Rivkin Center for Ovarian Cancer Research
state: Washington
Study officials:
affiliation: Swedish Medical Center
name: Pamela Paley, MD
role: PRINCIPAL_INVESTIGATOR
References: