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 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT04515459
Eligibility Criteria:
Inclusion Criteria:
1. Age \> or = 16 years old.
2. Patient with a diagnosis of bone or soft-tissue sarcoma confirmed by the "Réseau de Relecture en Pathologie Sarcomateuse (RRePS)"
3. Tumour localized in the lower or upper limb.
4. Localized or metastatic disease (in case of metastatic disease, the optimal surgical treatment for the primary tumor must be performed).
5. Indication of neoadjuvant treatment (radiotherapy and/or chemotherapy) according to the Multidisciplinary Concertation Meeting.
6. Inclusion before the initiation or during neoadjuvant treatment. In both cases, surgery must be scheduled between 6 and 10 weeks after inclusion, to permit the completion of the surgical prehabilitation.
7. Patient must provide written informed consent prior to any study-specific procedure. For minor patients, the holder(s) of parental authority must sign the informed consent and the patient's assent must be obtained.
8. Patient affiliated to the French social security system.
Exclusion Criteria:
1. Metastatic disease without optimal surgery planned of the primary tumour.
2. Any disease or medical condition that could interfere with study procedure, or that could, according to the judgment of investigator, expose the patient to an unacceptable risk.
3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
4. Any psychological, familial, geographic or social situation preventing compliance with the medical monitoring and/or with study procedure.
5. Pregnant or breastfeeding patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT04515459
Study Brief:
Protocol Section:
NCT04515459