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 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT01849133
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 48 and \< 75
* Clinical mammographic/ultrasound diagnosis of unicentric carcinoma, with ultrasound diameter ≤2.5 cm. Advisable, but not mandatory, the execution of mammoscintigraphy with MDP-99mTc (Methyl diphosphonate technetium-99m) : this procedure allows the bone staging and the mapping of eventual multi-focality/multi-centricity of the breast neoplasm.
* No previous therapy (biopsy included) for breast cancer in other Institutions.
* Patients with non-palpable lesions will undergo preoperative centering and stereotactic and/or ultrasound-guided cytology (the execution of this last procedure is not mandatory).
* Adequate information to the patient and informed consent.
Exclusion Criteria:
* Ductal or lobular non-infiltrating carcinoma.
* Paget disease.
* Tumor in close proximity to the skin.
* Tumor in the axillary tail.
* Documented multi-centricity/multi-focality of the tumor.
* Patients who underwent excisional biopsy in other Institutions.
* Histology different from carcinoma.
* Personal anamnesis positive for malignancy (basocellular carcinoma, in situ carcinoma of the cervix, contralateral breast cancer free of disease after 15 years of follow-up excluded).
* General contraindications to regular follow-up or radiotherapy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
48 Years
Maximum Age:
75 Years
Study:
NCT01849133
Study Brief:
Protocol Section:
NCT01849133