Impact of Image-defined Risk Factors on the Outcome of Patients With Neuroblastoma: A Retrospective Study

Recruiting

• Conditions: Neuroblastoma

• Registration Number: NCT02558244
• Lead Sponsor: Assiut University

Brief Summary

The aim of this study is to evaluate Image-defined Risk Factors (IDRF) in patients with neuroblastoma, at the time of their initial presentation, as a prognostic factor for prediction of subsequent outcome \& complications related to surgery, in the accordance with the experience of South Egypt Cancer Institute (SECI), which is the largest referral site in Upper Egypt.

Detailed Description

Background:

Neuroblastoma is the third most common childhood cancer, after leukemia and brain tumors, and is the most common solid extracranial tumor in children.

The concept of surgical risk factors in neuroblastoma surgery was introduced with the European multicenter study (LNESG1) study.

In 2005 the International Neuroblastoma Risk Group (INRG) Task Force, representing all major co-operative pediatric cancer groups, adopted the principle of surgical risk factors and incorporated it in the INRG Staging System. The INRG Task Force preferred the term Image-Defined Risk Factors (IDRF) to surgical risk factors, and agreed upon a list of IDRF.

Patients \& Methods:

This retrospective study will be carried out by reviewing the medical records of patients with neuroblastoma seen at the pediatric oncology department, in the period from 2001 January till 2015 December.

Data from Patients' medical records will be gathered, Pathologic diagnosis of neuroblastoma will be verified before the enrollment into the study. As an initial imaging was done for all patients at presentation, as a routine for diagnosis \& staging, the reports of the computed tomography scans will be reviewed for verification of the presence or absence of the IDRF. This historical cohort will be followed forward with time for ascertainment of the role of surgery in treatment, and treatment outcomes of these patients. Any complications occurred due to surgery will be reported, as collected from surgical reports of these patients.

Study Timeline

• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Study Start: 2016-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24
• Primary Completion: 2023-09
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients whose age less than 19 years.
• Patients diagnosed with non-metastatic neruoblastoma.

Exclusion Criteria

• Patients whose age more than 18 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Participants will be retrospectively followed forward in time from the date of diagnosis till the primary completion date of the study, an expected average of 5 years	Time from the date of diagnosis until death from any cause
Event Free Survival (EFS)	Participants will be retrospectively followed forward in time from the date of diagnosis till the primary completion date of the study, an expected average of 5 years	Time from the date of diagnosis until disease progression, or death for any reason.

Secondary Outcome Measures

Name	Time	Method
Complications of Surgery	Participants will be retrospectively followed forward in time from the date of surgical operation till the occurence of any complication due to surgery, an expected average of 3 months

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt