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Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer (OCEDP)

Primary Purpose

Ovarian Diseases, Ovarian Neoplasms

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Laboratory Tumor Marker Analysis
Transvaginal Ultrasound
Health Status Questionnaire
Sponsored by
Swedish Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ovarian Diseases focused on measuring Women with increased risk for developing ovarian cancer, Women diagnosed with reproductive cancer, Women with relatives who have had ovarian or breast cancer

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Marsha Rivkin Center for Ovarian Cancer Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ovarian Cancer Screening

Arm Description

CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Performing health status questionnaires over time

Full Information

First Posted
November 30, 2010
Last Updated
January 15, 2016
Sponsor
Swedish Medical Center
Collaborators
Fred Hutchinson Cancer Center, The Marsha Rivkin Center for Ovarian Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT01292733
Brief Title
Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer
Acronym
OCEDP
Official Title
Ovarian Cancer Early Detection Screening Program
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Closed per local IRB due to advancements in standard ovarian cancer screening.
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Medical Center
Collaborators
Fred Hutchinson Cancer Center, The Marsha Rivkin Center for Ovarian Cancer Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ovarian Cancer Screening
Arm Type
Experimental
Arm Description
CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires
Intervention Type
Other
Intervention Name(s)
Laboratory Tumor Marker Analysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Transvaginal Ultrasound
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Health Status Questionnaire
Intervention Description
Performed every 6 months, these questionnaires will ask about your health and medical history, environmental exposures, and family history.
Primary Outcome Measure Information:
Title
Measuring for elevated levels of tumor marker CA-125 in the blood over time.
Time Frame
Average expected time of 1 year
Secondary Outcome Measure Information:
Title
Performing transvaginal ultrasounds to look for any abnormalities over time.
Description
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
Title
Performing health status questionnaires over time
Time Frame
Average expected time of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Paley, MD
Organizational Affiliation
Swedish Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marsha Rivkin Center for Ovarian Cancer Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.marsharivkin.org/research/screening.html
Description
Marsha Rivkin Center for Ovarian Cancer Research

Learn more about this trial

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

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