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

NCT01292733TerminatedEARLY PHASE1INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Swedish Medical Center

Enrollment

534

Start Date

2009-08-01

Completion Date

2015-12-01

Study Type

INTERVENTIONAL

Official Title

Ovarian Cancer Early Detection Screening Program

Interventions

Laboratory Tumor Marker AnalysisTransvaginal UltrasoundHealth Status Questionnaire

Conditions

Ovarian DiseasesOvarian Neoplasms

Eligibility

Age Range

30 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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

Time frame: Average expected time of 1 year

Secondary Outcomes

Performing transvaginal ultrasounds to look for any abnormalities over time.

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.

Time frame: Average expected time of 1 year

Performing health status questionnaires over time

Time frame: Average expected time of 1 year

Locations

Marsha Rivkin Center for Ovarian Cancer Research, Seattle, United States