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

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