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NCT06296732Recruiting

Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification

Source: ClinicalTrials.gov · Last updated 20 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
29 Feb 2024
Start date
19 Oct 2023
Primary completion date
26 Oct 2026
Lead sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
NCT number
NCT06296732

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 19 Oct 2023 to the primary completion date, 26 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe concomitant pathology, increasing anesthesiologic and surgical risks, via the desicion of the research physician or conclusion by multidisciplinary team in centers- participants.
  • Tumor volume does not technically allow to provide minimally-invasive surgery, based on the conclusion of multidisciplinary experts board team in centers- participants.
  • Therapy strategy: observation
    • \-

Other

  • 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.

Who the study is looking for

  • 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.
  • Age from 0 to 18 years.
  • Preoperative imaging (abdominal contrast-enhanced computed tomography (CT), performed no later than 14 days before the planned surgery).
  • Indications for surgery based on the decision of multidisciplinary experts board in centers- participants.
  • Written voluntary informed consent of the patient and / or his legal representative.

Age in the registry: 1 day to 18 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Research Institute of Pediatric Hematology, Oncology and Immunology
Coordinator of this site? Confirm its status
MoscowRussiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.