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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT00002934
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven low or intermediate grade ductal carcinoma in situ (DCIS) of the breast
* No greater than 2.5 cm in the greatest dimension
* OR
* Histologically proven high-grade DCIS of the breast
* No greater than 1 cm in greatest dimension
* Region of DCIS must be at least 2.5 mm in greatest dimension (mammographic estimate of size allowed where pathologic measurement is impossible)
* DCIS must be non-palpable; detected by a mammogram or found incidentally by a breast biopsy
* Pathologically confirmed negative margins of at least 3 mm
* Breast must be suitable for breast conserving therapy
* Proper tumor size versus breast size
* No carcinoma or suspicious mammogram findings in other breast sites
* No prior in situ or invasive breast cancer
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Greater than 5 years
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Cardiovascular:
* Not specified
Other:
* No other invasive malignancies within the past 10 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
* No known HIV infection
* No Paget's nipple disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Adjuvant tamoxifen allowed
Radiotherapy:
* No prior radiotherapy to breast
* No adjuvant radiotherapy
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00002934
Study Brief:
Protocol Section:
NCT00002934