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

Study Overview
=================
Brief 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.

Official Title
-----------------
Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Other: physiologic testing
* Procedure: study of high risk factors


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: physiologic testing|nan|
|Procedure: study of high risk factors|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the feasibility of prospective screening for ovarian cancer in high-risk patients. |  | baseline | 
| 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). |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian epithelial cancer