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 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT02759133
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 or over
* Patients suffering from unifocal or in situ invasive or ductal breast cancer proven by anatomopathologic analysis (biopsy).
* Non-palpable tumor measuring at least 5 mm (minimum size deemed sufficient for the lesion to be visible by ultrasound) and ≤ 30 mm, visible by ultrasound and constituting a mass.
* Patients needing conservative first surgery management by preoperative tumor localization. For women of childbearing age, an effective contraceptive is mandatory throughout the study and up to 6 months post-operatively.
* Patients who have been made aware of the information sheet and have given their written signed informed consent.
* Patients benefitting from social health insurance coverage.
Exclusion Criteria:
* Patients with a history of homolateral breast cancer.
* Patients who have undergone neoadjuvant chemotherapy.
* Multifocal or multicentric cancer.
* Metastatic breast cancer.
* Cancer presenting in the form of microcalcifications with no visible mass.
* Vulnerable patients: pregnant or breastfeeding women, women deprived of their freedom by administrative or judicial decree, adults subject to a legal protection order or unable to give their consent.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02759133
Study Brief:
Protocol Section:
NCT02759133