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: Phase II trial to study the effectiveness of monitoring CA-125 levels in screening for cancer in women who are at high risk of developing ovarian cancer.

Condition	Treatment or Intervention	Phase
ovarian epithelial cancer	Procedure: screening intervention  Procedure: study of high risk factors  Procedure: study of physiologic variables	Phase II

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.

Ages Eligible for Study:  30 Years and above,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Edward E. Partridge, MD,  Principal Investigator,  UAB Comprehensive Cancer Center   

Study ID Numbers:  CDR0000353332; UAB-120; UAB-0120
Record last reviewed:  March 2004
Record first received:  April 7, 2004
ClinicalTrials.gov Identifier:  NCT00080639
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-05