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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT00165256
Eligibility Criteria:
Inclusion Criteria:
* Patients must have high quality mammogram including magnification views of the area containing suspicious calcifications.
* A specimen radiograph is required. If the specimen radiograph does not assure removal of all suspicious microcalcifications, a post-operative mammogram showing removal of all suspicious calcifications is required.
* The clinical extent of DCIS must be less than or equal to 2.5 cm.
* Grade 1 or 2 DCIS; patients with lobular carcinoma-in-situ (LCIS) in addition to DCIS in the breast are eligible. Negative margins are not required on the LCIS.
* Patients must undergo a wide excision. A re-excision after the initial biopsy might be needed. Complete resection of the area of DCIS with a histologic margin of at least 1 cm must be achieved.
* Patients must be enrolled on this protocol within 3 months of the last surgical procedure.
Exclusion Criteria:
* Patients with invasive carcinoma including microinvasive disease
* Carcinoma found in the sampled lymph nodes if axillary dissection is done
* Patients with nipple discharge
* Patients with adjuvant chemotherapy or Tamoxifen
* Patients with a history of prior malignancies other than squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
* Patients with a history of ipsilateral or contralateral breast carcinoma or DCIS or simultaneous bilateral DCIS.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00165256
Study Brief:
Protocol Section:
NCT00165256