Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT00039559
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Participant meet the criteria for one of the following conditions:
* Participant has tested positive for a mutation in the breast cancer susceptibility gene 1 (BRCA1) or breast cancer susceptibility gene 2 (BRCA2) or has a first- or second-degree relative with a BRCA1 or BRCA2 mutation
* At least 2 ovarian or breast cancers (including ductal carcinoma in situ) have occurred among the participant and her first- and second-degree relatives within the same lineage
* Condition may be satisfied by multiple primary cancers in the same person
* Where breast cancer is required to meet this criterion, at least 1 breast cancer patient must have been pre-menopausal (age 50 and under at diagnosis if age at menopause unknown)
* Participant is of Ashkenazi Jewish ethnicity and either has had breast cancer or has 1 first-degree or 2 second-degree relatives with breast cancer (including ductal carcinoma in situ) or ovarian cancer
* Where breast cancer is required to meet this criterion, at least 1 breast cancer patient must have been pre-menopausal (age 50 and under at diagnosis if age at menopause unknown)
* Probability of carrying a BRCA1 or BRCA2 mutation exceeds 20% as calculated by BRCAPRO, given family pedigree of breast cancer (including ductal carcinoma in situ) and ovarian cancer
* Participant must have no prior or concurrent ovarian cancer (including low malignant potential (LMP) cancers) or primary papillary serous carcinoma of the peritoneum
* Participant must not be negative for the same BRCA1 or BRCA2 mutation for which a first- or second-degree relative has tested positive
* Participants who test negative for BRCA1 or BRCA2 mutation are still eligible if the pedigree or BRCAPRO criteria are satisfied, including Ashkenazi women who test negative for the three founder mutations
* Documentation of family history is by participant's self-report
* In relatives, ovarian cancer is defined as invasive ovarian epithelial cancers, fallopian tube cancers, or primary papillary serous carcinoma of the peritoneum
* Germ cell or granulosa tumors or LMP ovarian cancers do not qualify
* First- and second-degree relatives include half siblings of the participant or her first-degree relative
PATIENT CHARACTERISTICS:
Age:
* 30 and over
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* No hemophilia or other bleeding disorders
* No serious anemia
Hepatic:
* Not specified
Renal:
* Not specified
Pulmonary:
* No emphysema
Other:
* Not pregnant
* Fertile patients must use effective contraception
* No psychiatric, psychological, or other conditions that would preclude informed consent
* No concurrent untreated malignancy except nonmelanoma skin cancer
* No medical conditions that would preclude blood draws during study
* No chronic infectious disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 3 months since prior adjuvant anticancer chemotherapy
Endocrine therapy:
* Prior or concurrent adjuvant hormonal therapies (e.g., tamoxifen, leuprolide, or goserelin) allowed
* Concurrent hormonal therapies (e.g., tamoxifen) for prevention allowed
Radiotherapy:
* At least 3 months since prior adjuvant anticancer radiotherapy
Surgery:
* At least 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy)
* No prior prophylactic oophorectomy
Other:
* At least 5 years since prior non-hormonal treatment for metastatic malignancy
* No concurrent participation in other ovarian cancer early detection trials
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Study:
NCT00039559
Study Brief:
Protocol Section:
NCT00039559