Relapsing PolychondritisPRPNCT06019221
Pediatric Relapsing Polychondritis : Diagnosis and Management in a French Retrospective Study
An observational study of Relapsing Polychondritis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The incidence in pediatrics is very low (about 3.5 per million per year according to a 2015 study) and therefore the data on the pathology very poor, especially on the therapeutic level. Without appropriate treatment, the disabling sequelae, even involving the vital prognosis, are significant. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Relapsing Polychondritis
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2023to 18 Jan 2024
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Minor subject aged 1 to 17 years having atrophic polychondritis
Who may be able to join
- Minor subject aged 1 to 17 years
- Diagnosis of atrophic polychondritis between 01/01/2008 to 31/12/2022.
- Subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.
Who cannot join
- Subject (or his parents) having expressed his (their) opposition to participating in the study
- Associated pathologies that cannot be related to the diagnosis of atrophic polychondritis and whose prognosis can lead to biases in the efficacy and/or complications related to treatments.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Pédiatrie 1 - CHU de Strasbourg - France
Strasbourg, 67091
Ariane ZALOSZYC, MD, 33 3 88 12 77 42, ariane.zaloszyc@chru-strasbourg.fr
Sarah-Louisa MAHI, MD, 33 3 88 12 77 42, sarah-louisa.mahi@chru-strasbourg.fr
About this study
The incidence in pediatrics is very low (about 3.5 per million per year according to a 2015 study) and therefore the data on the pathology very poor, especially on the therapeutic level.
Without appropriate treatment, the disabling sequelae, even involving the vital prognosis, are significant. However, in paediatrics, therapeutic habits have been extrapolated from adult data and lack precision.
Read more
Existing treatments are almost composed of immunomodulatory and/or immunosuppressive treatments. Different therapeutic lines have been introduced over the years and a better understanding of the pathology. More recently, biotherapies have been introduced in this pathology, but data on their effectiveness remain limited. Data on the evolution under therapy in children are thus still poor.
Complications related to the pathology that can jeopardize the vital prognosis and the response to treatment for this pathology deserve to be studied in order to be known and if possible avoided.
The aim of the study is to describe French practices and compare the lines of treatment proposed for juvenile atrophic polychondritis.
- Conditions
- Relapsing Polychondritis
- Keywords
- Polychondritis, Relapsing Polychondritis, Pediatric Relapsing Polychondritis
- Medical subject headings
- Polychondritis, Relapsing
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic effectiveness of the various treatments proposed depending on the degree of initial clinical involvement
The aim of this study is to bring together the experiences of the various reference and competence centers in France concerning the clinical presentation, management and follow-up of children with relapsing polychondritis.
Measured: Files analysed retrospectively from from January 01, 2008 to December 31, 2022 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start18 Feb 2023
- Primary completion18 Jan 2024 (estimated)
- Study completion18 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing PolychondritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ariane ZALOSZYC, MD, Study director, University Hospitals of Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019221
- Sponsor's protocol ID
- 8783
- Acronym
- PRP
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 2 Nov 2023
- 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 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Relapsing Polychondritis : Diagnosis and Management in a French Retrospective Study
- ClinicalTrials.gov ID
- NCT06019221
- Acronym / sponsor ID
- PRP / 8783
- Conditions
- Relapsing Polychondritis
- Keywords
- Polychondritis, Relapsing Polychondritis, Pediatric Relapsing Polychondritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 18 Feb 2023 (actual)
- Primary completion
- 18 Jan 2024 (estimated)
- Study completion
- 18 Jan 2024 (estimated)
- First posted
- 31 Aug 2023 (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.
The incidence in pediatrics is very low (about 3.5 per million per year according to a 2015 study) and therefore the data on the pathology very poor, especially on the therapeutic level.
Without appropriate treatment, the disabling sequelae, even involving the vital prognosis, are significant. However, in paediatrics, therapeutic habits have been extrapolated from adult data and lack precision.
Existing treatments are almost composed of immunomodulatory and/or immunosuppressive treatments. Different therapeutic lines have been introduced over the years and a better understanding of the pathology. More recently, biotherapies have been introduced in this pathology, but data on their effectiveness remain limited. Data on the evolution under therapy in children are thus still poor.
Complications related to the pathology that can jeopardize the vital prognosis and the response to treatment for this pathology deserve to be studied in order to be known and if possible avoided.
The aim of the study is to describe French practices and compare the lines of treatment proposed for juvenile atrophic polychondritis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Minor subject aged 1 to 17 years having atrophic polychondritis
Key inclusion criteria (3 listed)
- Minor subject aged 1 to 17 years
- Diagnosis of atrophic polychondritis between 01/01/2008 to 31/12/2022.
- Subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.
Key exclusion criteria (2 listed)
- Subject (or his parents) having expressed his (their) opposition to participating in the study
- Associated pathologies that cannot be related to the diagnosis of atrophic polychondritis and whose prognosis can lead to biases in the efficacy and/or complications related to treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Therapeutic effectiveness of the various treatments proposed depending on the degree of initial clinical involvement
Time frame: Files analysed retrospectively from from January 01, 2008 to December 31, 2022 will be examined
The aim of this study is to bring together the experiences of the various reference and competence centers in France concerning the clinical presentation, management and follow-up of children with relapsing polychondritis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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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.
Ariane ZALOSZYC, MD study director
University Hospitals of Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Polychondritis, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariane ZALOSZYC, MD (33 3 88 12 77 42, ariane.zaloszyc@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic effectiveness of the various treatments proposed depending on the degree of initial clinical involvement (time frame: Files analysed retrospectively from from January 01, 2008 to December 31, 2022 will be examined). 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 2 Nov 2023.