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

Embryonal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02665676
• Other study ID #: Ped Embryonal Tumors SECI
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: April 2024

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Embryonal Neoplasms
• Neoplasms
• Neoplasms, Embryonal
• Neoplasms, Germ Cell and Embryonal

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Tulla M, Berthold F, Graf N, Rutkowski S, von Schweinitz D, Spix C, Kaatsch P. Incidence, Trends, and Survival of Children With Embryonal Tumors. Pediatrics. 2015 Sep;136(3):e623-32. doi: 10.1542/peds.2015-0224. — View Citation

Ward E, DeSantis C, Robbins A, Kohler B, Jemal A. Childhood and adolescent cancer statistics, 2014. CA Cancer J Clin. 2014 Mar-Apr;64(2):83-103. doi: 10.3322/caac.21219. Epub 2014 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	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
Primary	Event Free Survival (EFS)	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