Clinical trial NCT05454163: Post-radiotherapy Rhinosinusitis in Children
Official title: Evaluation of Chronic Rhinosinusitis in Children Managed for Cervicofacial Mesenchymal Malignancy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pediatric Cancer
Chronic Sinusitis
Keywords: Post-treatment chronic sinusitis
Pediatric cancer
Sinusitis
Quality of life
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Centre Oscar Lambret
First posted: 2022-07-12
Enrollment: 55
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population (called exposed) concerns all patients under 18 years of age managed for a head neck mesenchymal cancer between January 1, 2018 and December 31, 2024 in the pediatric surgery department of the Lille University Hospital.

The control population (called non-exposed) included children treated during the same period for a non-head neck mesenchymal malignant cancer

Brief summary: Chronic rhinosinusitis (CRS) is a frequent complication of facial cancer treatment, mainly related to radiotherapy. However, while radiological involvement is frequent, clinical expression seems less important.

Few studies have investigated the incidence of this condition in the pediatric population while its evolution seems to be very chronic even if a partial improvement may occur with time.

Our objective is therefore to study the impact of CSR in children treated for cancer of the cervicofacial region, to evaluate its incidence and medium-term evolution in order to determine whether it is necessary to set up a specific follow-up in these patients.

The clinical impact of CSR is assessed by a specific SNOT 22 questionnaire in children treated for a head-neck mesenchymal malignancy in comparison with a control population consisting of children treated for a mesenchymal malignancy of non-head-neck location.


Eligibility criteria: Inclusion Criteria:

* Study population: all patients under 18 years of age managed for a head neck mesenchymal cancer between January 1, 2018 and December 31, 2024
* Control population: all patient under 1 years of age managed for non -head neck mesenchymal cancer between January 1, 2018 and December 31, 2024

Exclusion Criteria:

* Patients with hematological tumors;
* Patients with mucociliary pathologies or proven allergic rhinitis before the diagnosis of cancer
* Patients who have required surgical treatment that has removed more than half of the sinus cavities
* Tumor recurrence at the time of inclusion
* Sinus surgery between the last radiological check-up and inclusion
* Administrative reasons: inability to receive informed information.

Primary outcomes:
measure: Impact of CRS in pediatric patients by Sino-Nasal Outcome Test-22 (SNOT 22)
timeFrame: >1 year to <4 years after the end of oncologic treatment
Secondary outcomes:
measure: Incidence of CRS in pediatric patients after head neck mesenchymal cancer management
timeFrame: 1 year after the end of the oncologic treatment
measure: Correlation between SNOT 22 and clinical assessment by PADORES score
timeFrame: >1 year to <4 years after the end of oncologic treatment
measure: Correlation between SNOT 22 and clinical assessment by lund-kennedy score
timeFrame: >1 year to <4 years after the end of oncologic treatment
measure: Correlation between SNOT 22 and radiological assessment by Lund-Mackay score
timeFrame: >1 year to <4 years after the end of oncologic treatment
measure: Radiological evolution of CRS by Lund-Mackay score
timeFrame: >1 year to <4 years after the end of oncologic treatment
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Pierre Fayoux, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: