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 @ 9:27 PM
Ignite Modification Date:
2025-12-24 @ 9:27 PM
NCT ID:
NCT06296732
Eligibility Criteria:
Inclusion Criteria:
1. Patients with neurogenic tumors meeting the criteria of groups I-III:
Group I
* low or moderate risk group according to pilot difficulty scoring system (less than 5 points, see supplementary material);
* no IDRF;
Group II:
* low or moderate risk group according to pilot difficulty scoring system (less than 5 points);
* patients with any number of IDRFs and without central tumor location and/or tumor extension across the midline and/or tumor volume (cm3)/patient height (m) ratio = 28 or more.
Group III:
* 2 and more IDRF + central tumor location and/or tumor extension across the midline;
* 2 and more IDRF + tumor volume (cm3)/patient height (m) ratio = 28 or more;
* 2 and more IDRF + 2 and more other risk factors according to pilot difficulty scoring system;
* 1 IDRF + tumor extension across the midline + tumor volume (cm3)/patient height (m) ratio = 28 or more.
2. Age from 0 to 18 years.
3. Preoperative imaging (abdominal contrast-enhanced computed tomography (CT), performed no later than 14 days before the planned surgery).
4. Indications for surgery based on the decision of multidisciplinary experts board in centers- participants.
5. Written voluntary informed consent of the patient and / or his legal representative.
Exclusion Criteria:
1. 3 and more IDRF + central tumor location and/or tumor extension across the midline and/or tumor volume (cm3)/patient height (m) ratio = 28 or more.
2. Severe concomitant pathology, increasing anesthesiologic and surgical risks, via the desicion of the research physician or conclusion by multidisciplinary team in centers- participants.
3. Tumor volume does not technically allow to provide minimally-invasive surgery, based on the conclusion of multidisciplinary experts board team in centers- participants.
4. Therapy strategy: observation
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Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
18 Years
Study:
NCT06296732
Study Brief:
Protocol Section:
NCT06296732