Post-radiotherapy Rhinosinusitis in Children

NCT ID: NCT05454163

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2025-10-31

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.

Conditions

Pediatric Cancer; Chronic Sinusitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Exposed patients

SNOT 22 questionnaire

Intervention Type: OTHER

22 items, score between 0 and 5; sum, minimum = 0, maximum = 110; higher score = higher impact on quality of life)

Non exposed patients

No interventions assigned to this group

Interventions

SNOT 22 questionnaire

22 items, score between 0 and 5; sum, minimum = 0, maximum = 110; higher score = higher impact on quality of life)

Intervention Type: OTHER

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Oscar Lambret

OTHER

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Fayoux, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Central Contacts

Pierre Fayoux, MD,PhD

Role: CONTACT

pierre.fayoux@chu-lille.fr

0320445962 ext. +33

Other Identifiers

2022-A00422-41

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0549

Identifier Type: -

Identifier Source: org_study_id