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

NCT ID: NCT00080639

Last Updated: 2013-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2007-06-30

Brief Summary

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.

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.

Conditions

Ovarian Cancer

Keywords

ovarian epithelial cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

physiologic testing

Intervention Type: OTHER

study of high risk factors

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward E. Partridge, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB-120

Identifier Type: -

Identifier Source: secondary_id

UAB-0120

Identifier Type: -

Identifier Source: secondary_id

CDR0000353332

Identifier Type: -

Identifier Source: org_study_id