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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02557048
Other study ID # Ped Head Neck Malig
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 10, 2019
Est. completion date December 2023

Study information

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

Clinical Trial Summary

The aim of the study is to identify demographic characteristics, various histopathologies, and site preferences for each disease entity of malignant head and neck tumors in pediatric oncology patients & treatment outcomes in these patients, according to experience at South Egypt Cancer Institute which is the largest referral site in Upper Egypt.


Description:

Background: Although head and neck masses represent a common entity in children, malignancy is uncommon. Only very limited data are available in the literature on the incidence of childhood cancer of the head and neck worldwide. Data from the United States National Cancer Institute database suggest that the head and neck are involved in 12 % of all childhood malignancies. The most common pediatric head and neck malignancies include Non Hodgkin lymphomas, Hodgkin lymphomas, rhabdomyosarcomas, thyroid malignancies, nasopharyngeal carcinomas (NPCs), salivary gland malignancies, and neuroblastomas. Patients & Methods: A hospital-based study, involving Pediatric cancer patients, those diagnosed with malignant tumors of the head & neck, 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. Clinico-laboratory data for each hisopathologic disease entity of various head & neck malignancies will be gathered. The demographic distribution for each disease entity in accordance with gender & age, and site preferences in these disease entities will be recorded. Treatment received & treatment outcomes will be verified and absolute frequencies & relative incidence of these disease entities will be calculated.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2023
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Patients whose age less than 19 years. - Patients diagnosed with a primary malignant tumor of the head & neck. Exclusion Criteria: - Patients whose age more than 18 years. - Patients diagnosed with a malignant disease primarily arising from the bone marrow. - Patients diagnosed with tumors of the central nervous system. - Patients diagnosed with retinoblastoma.

Study Design


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)

Chadha NK, Forte V. Pediatric head and neck malignancies. Curr Opin Otolaryngol Head Neck Surg. 2009 Dec;17(6):471-6. doi: 10.1097/MOO.0b013e3283323893. — View Citation

Gosepath J, Spix C, Talebloo B, Blettner M, Mann WJ. Incidence of childhood cancer of the head and neck in Germany. Ann Oncol. 2007 Oct;18(10):1716-21. doi: 10.1093/annonc/mdm278. Epub 2007 Jul 28. — 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
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