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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT02335957
Eligibility Criteria:
Inclusion Criteria:
1. Infiltrating, ductal carcinoma of the breast.
2. Treated with conservative surgery (tumorectomy or quadrantectomy) without lymphadenectomy.
3. Sentinel lymph node assessed by OSNA, with TTL in the range 250 - 15,000 copies/μL.
4. Age ≥ 18 yrs old.
5. Karnofsky Index ≥ 70 %.
6. Signed Informed Consent.
Exclusion Criteria:
1. Other types of breast cancer different from infiltrating ductal carcinoma.
2. Bilateral breast cancer.
3. Males.
4. Mastectomy or axillary homolateral lymph node dissection.
5. Previous thoracic irradiation therapy.
6. Systemic neoadjuvant therapy previous to surgery.
7. Contraindications of radiotherapy (pregnancy, severe collagen diseases).
8. Other neoplasms.
9. Severe associated comorbidities that, according to the investigator criteria, may interfere with the study evaluations.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02335957
Study Brief:
Protocol Section:
NCT02335957