- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01292733
Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer (OCEDP)
January 15, 2016 updated by: Swedish Medical Center
Ovarian Cancer Early Detection Screening Program
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
534
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98122
- Marsha Rivkin Center for Ovarian Cancer Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ovarian Cancer Screening
CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires
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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.
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.
Performed every 6 months, these questionnaires will ask about your health and medical history, environmental exposures, and family history.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measuring for elevated levels of tumor marker CA-125 in the blood over time.
Time Frame: Average expected time of 1 year
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Average expected time of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performing transvaginal ultrasounds to look for any abnormalities over time.
Time Frame: Average expected time of 1 year
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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.
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Average expected time of 1 year
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Performing health status questionnaires over time
Time Frame: Average expected time of 1 year
|
Average expected time of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pamela Paley, MD, Swedish Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
November 30, 2010
First Submitted That Met QC Criteria
February 8, 2011
First Posted (Estimate)
February 9, 2011
Study Record Updates
Last Update Posted (Estimate)
January 20, 2016
Last Update Submitted That Met QC Criteria
January 15, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Ovarian Diseases
Other Study ID Numbers
- IR 4707
- CRC 08108 (Other Identifier: Swedish Medical Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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