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Trial record 96 of 1321 for:    Recruiting, Not yet recruiting, Available Studies | "Head and Neck Neoplasms"

Head and Neck Cancer in Children: A Retrospective Study

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ClinicalTrials.gov Identifier: NCT02557048
Recruitment Status : Not yet recruiting
First Posted : September 22, 2015
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohammed Morsy, MD, 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.

Condition or disease
Head and Neck Neoplasms Cancer of Head and Neck Cancer of the Head and Neck Head and Neck Cancer Neoplasms, Head and Neck

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 Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Malignant Head and Neck Tumors in Children: A Retrospective Study
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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 reports will be retrospectively reviewed for data collection.
Criteria

Inclusion Criteria:

  • Patients whose age less than or equal to 18 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557048


Locations
Egypt
Assiut University Not yet recruiting
Assiut, Egypt, 71515
Contact: Ahmed M. Morsy, MD    +2 01003314522    ahmedmohammed7829@yahoo.com   
Principal Investigator: Ahmed M. Morsy, MD         
Principal Investigator: Badawy M. Ahmed, MD         
Principal Investigator: Khalid M. Rezk, MD         
Principal Investigator: Ameer M. Abuelgheet, MD         
Sponsors and Collaborators
Assiut University

Publications:
Responsible Party: Ahmed Mohammed Morsy, MD, Lecturer, Pediatric Oncology Department, Assiut University
ClinicalTrials.gov Identifier: NCT02557048     History of Changes
Other Study ID Numbers: Ped Head Neck Malig
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017

Keywords provided by Ahmed Mohammed Morsy, MD, Assiut University:
Childhood Cancer
Head and Neck Tumors
Pediatric Oncology

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site