Pediatric CancerPRRSCNCT05454163
Post-radiotherapy Rhinosinusitis in Children
An observational study of Pediatric Cancer and Chronic Sinusitis, run by University Hospital, Lille.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Cancer, Chronic Sinusitis
- What is being tested?
- SNOT 22 questionnaire
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Evaluation of Chronic Rhinosinusitis in Children Managed for Cervicofacial Mesenchymal Malignancy
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.
Read more
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
- Being tested
- SNOT 22 questionnaire
- Keywords
- Post-treatment chronic sinusitis, Pediatric cancer, Sinusitis, Quality of life
- Medical subject headings
- Neoplasms, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNOT 22 questionnaireOther
22 items, score between 0 and 5; sum, minimum = 0, maximum = 110; higher score = higher impact on quality of life)
| Study group | Role | What they receive |
|---|---|---|
| Exposed patients | Not described Receives: Other: SNOT 22 questionnaire | |
| Non exposed patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of CRS in pediatric patients by Sino-Nasal Outcome Test-22 (SNOT 22)
Measured: >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
Measured: 1 year after the end of the oncologic treatment
Correlation between SNOT 22 and clinical assessment by PADORES score
Measured: >1 year to <4 years after the end of oncologic treatment
Correlation between SNOT 22 and clinical assessment by lund-kennedy score
Measured: >1 year to <4 years after the end of oncologic treatment
Correlation between SNOT 22 and radiological assessment by Lund-Mackay score
Measured: >1 year to <4 years after the end of oncologic treatment
Radiological evolution of CRS by Lund-Mackay score
Measured: >1 year to <4 years after the end of oncologic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Oct 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Oscar Lambret
- Responsible party
- Sponsor
- Investigators
- Pierre Fayoux, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454163
- Sponsor's protocol ID
- 2021_0549
- Other IDs
- 2022-A00422-41
- Acronym
- PRRSC
- Status last verified
- May 2026
- First submitted
- 7 Jul 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chronic Rhinosinusitis in Children Managed for Cervicofacial Mesenchymal Malignancy
- ClinicalTrials.gov ID
- NCT05454163
- Acronym / sponsor ID
- PRRSC / 2021_0549
- Conditions
- Pediatric Cancer, Chronic Sinusitis
- Keywords
- Post-treatment chronic sinusitis, Pediatric cancer, Sinusitis, Quality of life
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Centre Oscar Lambret
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed patients | – | Other: SNOT 22 questionnaire |
| Non exposed patients | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNOT 22 questionnaire22 items, score between 0 and 5; sum, minimum = 0, maximum = 110; higher score = higher impact on quality of life) | Other | Exposed patients |
Primary outcome
Impact of CRS in pediatric patients by Sino-Nasal Outcome Test-22 (SNOT 22)
Time frame: >1 year to <4 years after the end of oncologic treatment
5 secondary outcomes
Incidence of CRS in pediatric patients after head neck mesenchymal cancer management
Time frame: 1 year after the end of the oncologic treatment
Correlation between SNOT 22 and clinical assessment by PADORES score
Time frame: >1 year to <4 years after the end of oncologic treatment
Correlation between SNOT 22 and clinical assessment by lund-kennedy score
Time frame: >1 year to <4 years after the end of oncologic treatment
Correlation between SNOT 22 and radiological assessment by Lund-Mackay score
Time frame: >1 year to <4 years after the end of oncologic treatment
Radiological evolution of CRS by Lund-Mackay score
Time frame: >1 year to <4 years after the end of oncologic treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Fayoux, MD,PhD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer and Chronic Sinusitis, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of CRS in pediatric patients by Sino-Nasal Outcome Test-22 (SNOT 22) (time frame: >1 year to <4 years after the end of oncologic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.