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 @ 10:18 PM
Ignite Modification Date:
2025-12-24 @ 10:18 PM
NCT ID:
NCT07230535
Eligibility Criteria:
Inclusion Criteria:
* Women aged 18 years and older
* Candidates who have already been selected to undergo mastectomy (of any kind) and immediate DIEP reconstruction by the breast MDT for the following indications:
1. Genetic mutation carriers undergoing risk-reducing mastectomy.
2. Ductal carcinoma in situ (DCIS) requiring mastectomy.
3. Early invasive breast cancer requiring mastectomy.
4. For those considered for Nipple Sparing Mastectomy randomisation arms the tumour must not have skin involvement and no evidence of invasive disease within 1cm of skin, nipple or Pec major muscle (as proven on MRI).
* Candidates for immediate breast reconstruction with DIEP reconstruction
* Fluent in English
* Fit for general anaesthetic
* Signed informed consent form
Exclusion Criteria:
* Advanced breast cancer with skin involvement for Nipple Sparing Mastectomy Arms
* Nipple involvement for Nipple Sparing Mastectomy Arms.
* Prior chest wall radiation therapy
* Pregnancy
* Lactation
* Patients with insufficient English to sign an informed consent (i.e. interpreter required).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07230535
Study Brief:
Protocol Section:
NCT07230535