Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women
Data Collection
Collected from today forward - ProspectiveCarcinoma, Ovarian Epithelial+16
+ Urogenital Diseases
+ Genital Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: June 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 30 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, United StatesSee the location