Post-radiotherapy Rhinosinusitis in Children
PRRSC
Evaluation of Chronic Rhinosinusitis in Children Managed for Cervicofacial Mesenchymal Malignancy
2 other identifiers
observational
55
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2022
Typical duration for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
July 12, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJuly 12, 2022
July 1, 2022
3 years
July 7, 2022
July 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Impact of CRS in pediatric patients by Sino-Nasal Outcome Test-22 (SNOT 22)
>1 year to <4 years after the end of oncologic treatment
Secondary Outcomes (5)
Incidence of CRS in pediatric patients after head neck mesenchymal cancer management
1 year after the end of the oncologic treatment
Correlation between SNOT 22 and clinical assessment by PADORES score
>1 year to <4 years after the end of oncologic treatment
Correlation between SNOT 22 and clinical assessment by lund-kennedy score
>1 year to <4 years after the end of oncologic treatment
Correlation between SNOT 22 and radiological assessment by Lund-Mackay score
>1 year to <4 years after the end of oncologic treatment
Radiological evolution of CRS by Lund-Mackay score
>1 year to <4 years after the end of oncologic treatment
Study Arms (2)
Exposed patients
Non exposed patients
Interventions
22 items, score between 0 and 5; sum, minimum = 0, maximum = 110; higher score = higher impact on quality of life)
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
- Administrative reasons: inability to receive informed information.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Lillelead
- Centre Oscar Lambretcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Fayoux, MD,PhD
University Hospital, Lille
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2022
First Posted
July 12, 2022
Study Start
October 1, 2022
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
July 12, 2022
Record last verified: 2022-07