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

Ovarian Neoplasms Clinical Trial

— OCEDP  

Official title:

Ovarian Cancer Early Detection Screening Program

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01292733
• Other study ID #: IR 4707
• Secondary ID: CRC 08108
• Status: Terminated
• Phase: Phase 0
• First received: November 30, 2010
• Last updated: January 15, 2016
• Start date: August 2009
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Swedish Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 534
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Ovarian Diseases
• Ovarian Neoplasms

Intervention

Other:
• Laboratory Tumor Marker Analysis
Performed every 6 months, these blood samples will be drawn to measure the concentration of CA125 tumor marker. Remaining samples will be stored in a specimen repository for use in future research for ovarian and breast cancer tumor markers.
• Transvaginal Ultrasound
Performed annually, these pelvic ultrasounds will be used used to look for 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.
• Health Status Questionnaire
Performed every 6 months, these questionnaires will ask about your health and medical history, environmental exposures, and family history.

Locations

Country	Name	City	State
United States	Marsha Rivkin Center for Ovarian Cancer Research	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Swedish Medical Center	Fred Hutchinson Cancer Research Center, The Marsha Rivkin Center for Ovarian Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring for elevated levels of tumor marker CA-125 in the blood over time.		Average expected time of 1 year	No
Secondary	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.	Average expected time of 1 year	No
Secondary	Performing health status questionnaires over time		Average expected time of 1 year	No

External Links

•   Marsha Rivkin Center for Ovarian Cancer Research