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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT01136369
Eligibility Criteria:
Inclusion Criteria:
* Male or Female patients, over the age of 18, diagnosed pre-surgically with T1 or T2 breast cancer and scheduled for surgery including sentinel node dissection.
* Patients who have read and understand the informed consent form and are capable and willing to provide written informed consent.
Exclusion Criteria:
* Patients diagnosed pre-surgically with large or locally advanced (T3 and T4) breast cancers.
* Patients diagnosed with inflammatory breast cancer.
* Patients diagnosed with ductal carcinoma in situ (DCIS) when breast conserving is to be done.
* Patients who are pregnant, as confirmed by a patient/treating physician interview.
* Patients with suspicious palpable axillary lymph nodes.
* Patients currently being treated for or previously diagnosed with, another type of carcinoma.
* Patients who have undergone prior non-oncologic breast surgery or axillary surgery.
* Patients who have received pre-operative systemic therapy.
* Patients who are incapable of providing written informed consent.
* Patients who have been judged to be inappropriate by a medical care provider (i.e. surgeon, oncologist, pathologists, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01136369
Study Brief:
Protocol Section:
NCT01136369