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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT04356235
Eligibility Criteria:
Inclusion Criteria:
* Under the age of 65 with uni- or bilateral primary breast cancer ( clinical Stage 0-III), needing modern skin sparing mastectomy, nipple sparing mastectomy or areola sparing mastectomy independently of the axillary surgery, having immediate or delayed-immediate implant based reconstrucion on the ipsilateral side and symmetrisation on the contralateral side ( mastopexy and/or implant based reconstruction and/or breast sling with ultrapro mesh)
* Control group: patients under 65 years with unilateral simplex mastectomy without breast reconstruction
Exclusion Criteria:
* In case the patient does not volunteer for the examination or the follow-ups
* Age above 65 years or poor general health condition, where the estimated life expectancies would be less than 2 years even without the tumorous disease
* Malignant invasive tumor in the past history (except for non-melanoma skin tumors)
* Mastectomyand reconstruction performed due pregnancy associated breast cancer
* Prior breast surgery (e.g. aesthetic surgery, mastopexy) and/or radiotherapy on the breast or in the axilla
* Malignant tumor is not removed completely with pathological examination
* Severe non-surgical (e.g. radiotherapy) complication, which could influence the aesthetic and functional results
* Autoimmune diseases
* Mastitis carcinomatosa
* Lymphangitis carcinomatosa
* Open wound therapy due SSI
* Long-term steroid usage, which changed the skin's quality and structure
* Patient under foster care, or psychically non-cooperative patient
* If breast correction performed during the 5 years follow up
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04356235
Study Brief:
Protocol Section:
NCT04356235