NCT06296732 Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification
| NCT ID | NCT06296732 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
| Condition | Neuroblastoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-10-19 |
| Primary Completion | 2026-10-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-10-19 with a primary completion date of 2026-10-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Surgery plays significant role in treatment of neurogenic tumors, both for benign ganglioneuroma and for high risk neuroblastoma. The world literature has accumulated large experience in laparoscopic surgery for abdominal neuroblastoma. The presence of IDRF (image-defined risk factors) and tumor size (\>4-7 cm) are considered as common contraindications for minimally invasive surgery in neuroblastoma. However, the recent studies have shown that presence of IDRF is not an absolute contraindication for laparoscopic surgery. This open-label, nonrandomized, observational, phase III evaluates role and weight of different surgical risk factors (including IDRF, tumor size, tumor localization, tumor volume/patient height ratio, previous open surgical procedures, previous chemotherapy etc.) in the laparoscopic neuroblastoma resections. The aim of this study is to create novel risk factors scoring system for laparoscopic surgery in abdominal neuroblastoma.
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 \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06296732 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 18 Years, studying Neuroblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06296732 currently recruiting?
Yes, NCT06296732 is actively recruiting participants. Contact the research team at d.g.akhaladze@gmail.com for enrollment information.
Where is the NCT06296732 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT06296732 clinical trial?
NCT06296732 is sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology. The trial plans to enroll 200 participants.