Embryonal Tumors of Infancy & Childhood: South Egypt Cancer Institute Experience

July 21, 2023 updated by: Ahmed Mohammed Morsy, MD, Assiut University
The aim of this study is to investigate demographic & disease characteristics of pediatric cancer patients diagnosed with one of embryonal tumors to identify the prevalence, the spectrum of these disease entities & treatment outcomes in these patients.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Background:

Embryonal tumors arise from cells that are normally present in the developing embryo and originate in developing tissues and organ systems. These tumors occur almost exclusively in children, and are usually diagnosed in children before age 5 years.

The group is heterogeneous and includes relatively common pediatric tumors as well as rare tumors. Three common types of embryonal tumors in children are neuroblastoma, Wilms tumor (WT), and retinoblastoma. Other embryonal tumors, include medulloblastoma and rhabdomyosarcoma.

Patients & Methods:

From January 2001 to December 2015, retrieval & analysis of the medical records of pediatric patients with embryonal tumors will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. These data will be categorized according to demographic characteristics, clinico-pathologic features, treatment modalities received, and outcomes of treatments in these patients.

Study Type

Observational

Enrollment (Estimated)

420

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:
          • 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 any of embryonal neoplasms, 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 or equal to 18 years.
  • Patients diagnosed with any of embryonal neoplasms.

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 initiation of treatment till the primary completion date of the study, an expected average of 5 years
Time from the date of initiation of treatment until death from any cause
Participants will be retrospectively followed forward in time from the date of initiation of treatment 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 initiation of treatment till the primary completion date of the study, an expected average of 5 years
Time from the date of initiation of treatment until disease progression, or death for any reason
Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years

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

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 (Actual)

July 1, 2019

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimated)

January 28, 2016

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

  • Ped Embryonal Tumors SECI

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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