Head and Neck Cancer in Children: A Retrospective Study

Recruiting

• Conditions: Cancer of Head and Neck; Head and Neck Neoplasms; Head and Neck Cancer; Cancer of the Head and Neck; Neoplasms, Head and Neck

• Registration Number: NCT02557048
• Lead Sponsor: Assiut University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Study Start: 2019-01-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	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
Event Free Survival (EFS)	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.

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt