NCT02557048

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
3.3 years until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

4.8 years

First QC Date

September 21, 2015

Last Update Submit

July 21, 2023

Conditions

Keywords

Childhood CancerHead and Neck TumorsPediatric Oncology

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Patients whose age less than 19 years.
  • Patients diagnosed with a primary malignant tumor of the head \& neck.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

Related 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.

    PMID: 19745735BACKGROUND
  • 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.

    PMID: 17660492BACKGROUND

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Pediatric Oncology Department

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 22, 2015

Study Start

January 10, 2019

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations