Clinical trial NCT02557048: Head and Neck Cancer in Children: A Retrospective Study
Official title: Malignant Head and Neck Tumors in Children: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Neoplasms
Cancer of Head and Neck
Cancer of the Head and Neck
Head and Neck Cancer
Neoplasms, Head and Neck
Keywords: Childhood Cancer
Head and Neck Tumors
Pediatric Oncology
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 120
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: 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.

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.

Eligibility criteria: 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.

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: 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.
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.