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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT05142202
Eligibility Criteria:
Inclusion Criteria:
* stage 0-II breast cancer
* Invasive ductal carcinoma (NOS, NST, other subtypes), invasive lobular carcinoma, ductal carcinoma in situ (DCIS)
* Invasive carcinoma/DCIS, which is unifocal and unicentric
* pT1-2, maximal tumor size \< 3 cm
* pN0 (no metastases to the nodes)
* LVI(-) - no lymphovascular invasion
* M0 (no distant metastases)
* Surgical margins free of cancer (no tumor on ink) in each direction; in the case of DCIS, the minimum margin of 2 mm in each direction
* Lack of indications to chemotherapy/immunotherapy pre- or postsurgically (e.g., triple-negative, HER2-positive breast cancer)
* Treatment start not later than 12 weeks after surgery (optimally 4-8 weeks, after wound healing)
* Informed handwritten signed patient's consent
Exclusion Criteria:
* stage III-IV breast cancer
* pT2-4, maximal tumor size ≥ 3 cm
* surgical margins cannot be properly microscopically assessed
* EIC(+) - presence of extensive intraductal component
* Paget's disease or microscopically assessed skin involvement
* pN1-3M1 (presence of nodal or distant metastases)
* pre- or postsurgical indications for chemotherapy/immunotherapy
* other cancer (less than five years at time of recruitment) except skin cancer or cured FIGO 0-I cervical cancer
* time of pregnancy or lactation
* collagen disorders (congenital or acquired)
* psychiatric disorder disabling patient's compliance
* breast appearance or postsurgical status disabling safe interstitial multicatheter implantation
* lack of informed handwritten signed patient's consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT05142202
Study Brief:
Protocol Section:
NCT05142202