Post-radiotherapy Rhinosinusitis in Children | NCT05454163

Studies
Post-radiotherapy Rhinosinusitis in Children

NCT05454163

Sponsor

University Hospital, Lille

Status

Withdrawn

Last Update Posted

May 22, 2026Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Pediatric Cancer
Chronic Sinusitis

Interventions

SNOT 22 questionnaire

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2022-A00422-41	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Oct 1, 2023Actual

Completion Date

Oct 1, 2023Actual

First Submitted Date

Jul 7, 2022

First Submission Date that Met QC Criteria

Jul 7, 2022

First Posted Date

Jul 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2026

Last Update Posted Date

May 22, 2026Actual

Name	Class
Centre Oscar Lambret	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exposed patients			Other: SNOT 22 questionnaire
Non exposed patients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SNOT 22 questionnaire	Other	22 items, score between 0 and 5; sum, minimum = 0, maximum = 110; higher score = higher impact on quality of life)	Exposed patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Pierre Fayoux, MD,PhD	University Hospital, Lille	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D012852	Sinusitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010254	Paranasal Sinus Diseases
D009668	Nose Diseases

Browse Leaves

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Browse Branches

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