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

July 21, 2023 updated by: Ahmed Mohammed Morsy, MD, Assiut University
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • Assiut University
        • Contact:
        • Principal Investigator:
          • Ahmed M. Morsy, MD
        • Principal Investigator:
          • Khalid M. Rezk, MD
        • Principal Investigator:
          • Ameer M. Abuelgheet, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric cancer patients, those diagnosed with Neuroblastoma, in the period from 2001 January till 2015 December, and received treatment at the pediatric oncology department, their medical records will be retrospectively reviewed for data collection.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 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
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
Event Free Survival (EFS)
Time Frame: 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.
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications of Surgery
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimated)

September 23, 2015

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Image-defined RF NB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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