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Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification

Study acronym: ANLAP-R
StatusRecruiting
PhaseNot specified
Started2023-10-19
View on ClinicalTrials.gov ↗

Amendment history

2024-05-17
minor
Study Status, Sponsor/Collaborators v2
Collaborators1 entry, revised
University Medical Center, Corporate Fund AstanaKazakhstan
2024-05-13
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v1
Collaborators1 entry, revised
University Medical Center Corporate Fund University Medical CentreAstana
2024-02-29
minor
Original filing
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.
Trial Details
NCT Number NCT06296732
Lead Sponsor Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Collaborators: University Medical Center, Kazakhstan
Conditions Neuroblastoma, Ganglioneuroma, Ganglioneuroblastoma
Enrollment 200 participants
Start Date 2023-10-19
Primary Completion 2026-10-26 (estimated)
Study Completion 2031-11-01 (estimated)
Updated on ClinicalTrials.gov 2024-05-20