Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

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

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.

Eligibility: 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

Relevance to patient case: not relevant