ca-125 in screening patients at high risk for ovarian cancer

Conditions: 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.

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 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

Keywords: ovarian epithelial cancer