Clinical trial NCT02665676: Embryonal Tumors of Infancy & Childhood: South Egypt Cancer Institute Experience
Official title: Embryonal Tumors of Infancy & Childhood: South Egypt Cancer Institute Experience
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasms, Embryonal
Embryonal Neoplasms
Keywords: Childhood Cancer
Pediatric Oncology
Embryonal Neoplasms
Embryonic Neoplasms
Embryonic Tumors
Embryonal Tumors
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 420
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 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
measure: Event Free Survival (EFS)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
citation: 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.
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.