Ovarian Cancer 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.
Full 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 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Birmingham Alabama, 35294, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.