CA-125 in Screening Patients at High Risk for Ovarian Cancer

August 1, 2013 updated by: University of Alabama at Birmingham

Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women

RATIONALE: Measuring levels of CA 125 in blood samples of women who have a high risk of developing ovarian cancer may help doctors detect cancer early and plan more effective treatment.

PURPOSE: This phase II trial is studying CA-125 levels in screening for cancer in women who are at high risk of developing ovarian cancer.

Study Overview

Status

Withdrawn

Conditions

Ovarian Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

Determine the feasibility of prospective screening for ovarian cancer in high-risk patients.
Determine normal ranges and distributions of CA 125 within and between these patients (with subclassification by menopausal status, estrogen replacement therapy usage, and prophylactic oophorectomy).

Secondary

Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients.

OUTLINE: This is a multicenter, pilot study.

Patients undergo blood collection and CA 125 levels are measured at baseline and then every 3 months for 1-2 years. Patients may be referred for an ovarian ultrasound if indicated by the CA 125 results.

Patients are followed at 6 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 2,400 patients will be accrued for this study within 1 year.

Study Type

Observational

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

United States
- Alabama
  - Birmingham, Alabama, United States, 35294-3300
    - Comprehensive Cancer Center at University of Alabama at Birmingham

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

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women know to be at high risk for ovarian cancer

Description

DISEASE CHARACTERISTICS:

At high risk for developing ovarian cancer, as determined by meeting criteria for 1 of the following:
- Family history of at least 2 ovarian or breast* cancers among the patient and first- and second-degree relatives within the same lineage**
  - If breast cancer* is required to meet this criterion, at least 1 breast cancer* must be premenopausal (diagnosed at age 50 or under if menopausal status unknown) NOTE: **Multiple primary cancers in the same person satisfies this criterion
- Ashkenazi Jewish ethnicity and meets criteria for 1 of the following:
  - Prior breast cancer* diagnosis
  - One first-degree or 2 second-degree relatives with breast* or ovarian cancer
    - If breast cancer is required to meet this criterion, at least 1 breast cancer* must be premenopausal (diagnosed at age 50 or under if menopausal status unknown)
- Probability of BRCA1 or BRCA2 mutation greater than 20%, as determined by BRCAPRO 95% posterior probability interval
  - This criterion includes the following situations for which BRCAPRO is not required:
    - Tested positive for a BRCA1 or BRCA2 mutation (100% probability)
    - First- or second-degree relative with a BRCA1 or BRCA2 mutation NOTE: *Including ductal carcinoma in situ
No ovarian cancer, including low malignant potential cancers or primary papillary serous carcinoma of the peritoneum

PATIENT CHARACTERISTICS:

Age

30 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

No hemophilia
No other bleeding disorders

Hepatic

Not specified

Renal

Not specified

Pulmonary

No emphysema

Other

Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
No psychiatric or psychological condition that would preclude giving informed consent
No concurrent untreated malignancy except nonmelanoma skin cancer
No other medical condition that would preclude blood draws (e.g., chronic infectious disease)

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

More than 3 months since prior adjuvant chemotherapy for cancer

Endocrine therapy

Concurrent adjuvant hormonal therapy (e.g., tamoxifen, leuprolide, or goserelin) allowed

Radiotherapy

More than 3 months since prior adjuvant radiotherapy for cancer

Surgery

More than 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy)
Prior prophylactic oophorectomy allowed

Other

More than 5 years since prior treatment (excluding hormonal therapy) for metastatic malignancy
No concurrent participation in other ovarian cancer early detection trials

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

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the feasibility of prospective screening for ovarian cancer in high-risk patients. Time Frame: baseline	baseline
Determine normal ranges and distributions of CA 125 within and between these patients (with subclassification by menopausal status, estrogen replacement therapy usage, and prophylactic oophorectomy). Time Frame: baseline	baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients. Time Frame: baseline	baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Edward E. Partridge, MD, University of Alabama at Birmingham

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

June 1, 2003

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

April 7, 2004

First Submitted That Met QC Criteria