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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT05490433
Eligibility Criteria:
Inclusion Criteria:
* Adult women (≥19 years) scheduled to undergo therapeutic mastectomy for breast cancer who desire immediate breast reconstruction (IBR).
* Breast cancer classified as clinical TNM stage 0 to IIIA, based on preoperative evaluation according to the 8th edition of the AJCC anatomic staging system.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
* Patients scheduled for breast-conserving surgery or deemed ineligible for immediate breast reconstruction (IBR).
* Clinical evidence of nipple or skin involvement on preoperative evaluation.
* Pregnant or breastfeeding women.
* Tumors consisting exclusively of lobular carcinoma in situ (LCIS).
* Paget's disease of the breast.
* Inflammatory breast cancer.
* Male breast cancer.
* Clinical stage IIIB-IV disease on preoperative evaluation.
* breast size equal to or larger than cup E
* History of breast cancer or bilateral breast cancer (including metachronous or synchronous disease).
* History of non-breast malignancy, with the exception of non-melanoma skin cancer or papillary/follicular thyroid carcinoma.
* Special histologic subtypes of breast tumors (e.g., phyllodes tumor, sarcoma, lymphoma).
* Age \>70 years.
* American Society of Anesthesiologists (ASA) physical status classification grade ≥4.
* Inability to provide informed consent.
* History of prior chest radiotherapy.
* Patients who have not undergone preoperative testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), which is required for liability insurance coverage.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT05490433
Study Brief:
Protocol Section:
NCT05490433