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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT06071234
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed diagnosis of breast cancer
* Age: 18 to 70 years old
* No infiltration of the nipple-areola complex and negative histopathology of the nipple basal margins;
* Participants who meet the indications for breast conserving surgery require total mastectomy and reconstruction;
Exclusion Criteria:
* Inability to tolerate surgery or subjective desire not to undergo nipple-sparing mastectomy;
* Participants with clinical or imaging evidence of preoperative involvement of the nipple/areolar region, including Paget's disease, nipple spillage, inflammatory breast cancer, and/or imaging findings suggesting malignant involvement of the nipple or subareolar tissues, according to the 2023 NCCN guideline recommendations, where retaining the NAC fails to yield negative margins;
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06071234
Study Brief:
Protocol Section:
NCT06071234