Pulmonary Langerhans Cell HistiocytosisPsyHistioNCT05114304
Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis
An observational study of Pulmonary Langerhans Cell Histiocytosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Pulmonary Langerhans cell histiocytosis (PLCH) is a rare disease, of unknown etiology, that occurs almost exclusively in smokers.The clinical experience suggests a high prevalence of anxiety symptoms and an addictive profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Langerhans Cell Histiocytosis
- What is being tested?
- Evaluation of co-morbid psychiatric disorders
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2021to Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with pulmonary Langerhans cell histiocytosis
Who may be able to join
- Patients of 18 years of age or older with PLCH diagnosed at adulthood
- Patients affiliated to the French Health Care System
- Informed patients
Who cannot join
- Patient unable to understand the interview (language barrier)
- Patient under guardianship or curatorship
- Patient under AME (French medical help for foreigners)
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Saint-Louis, Centre de référence national des histiocytoses, Service de Pneumologie
Paris
Abdellatif TAZI
About this study
Official title: Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis: an Exploratory Study
Pulmonary Langerhans cell histiocytosis (PLCH) is a rare disease, of unknown etiology, that occurs almost exclusively in smokers.The clinical experience suggests a high prevalence of anxiety symptoms and an addictive profile. However, no study to date has precisely investigated the prevalence of co-morbid psychiatric disorders in this population.The aim of the study is to evaluate the prevalence of co-morbid psychiatric disorders in adult PLCH patients.
This study should allow:
- to assess the prevalence of psychiatric disorders co-morbid in PLCH patients
- a targeted and more effective management of patients
- a better response rate to smoking and cannabis weaning, that represents a major goal for these patients.
- Conditions
- Pulmonary Langerhans Cell Histiocytosis
- Being tested
- Evaluation of co-morbid psychiatric disorders
- Medical subject headings
- Histiocytosis, Langerhans-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of co-morbid psychiatric disordersOther
Added scales :
- Mini Internationnal Neuropsychiatric Interview
- Fagerström test
- DSM-5 Scale
Additional dosage : - a urine sample will be taken to evaluate the presence of tobacco and nicotine breakdown products and the presence of various toxics
Expired carbon monoxide for patients using nicotine substitutes
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Langerhans cell histiocytosis (PLCH) | Adults with pulmonary Langerhans cell histiocytosis Receives: Other: Evaluation of co-morbid psychiatric disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with at least one of the disorders detailed in the Mini International Neuropsychiatric Interview (MINI) test
The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a structured diagnostic interview (40 minutes duration), exploring in a standardized way the main psychiatric disorders of Axis I of the DSM-IV TR (American Psychiatric Association), namely 14 items with a binary result for each specified disorder
Measured: at inclusion
Secondary outcomes (6)
Proportion of patients with at least one comorbid addictive disorder among: tobacco, alcohol, cannabis, benzodiazepines, cocaine, opiates
Definition and diagnosis of addictive disorder will be assessed with Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
Measured: at inclusion
Proportion of patients with active tobacco consumption with or without comorbid psychiatric disorder
Tobacco consumption will be assessed by Fagerström survey and DSM-5, cotinine in urine quantification and expired carbon monoxide for patients using nicotine substitutes. Fargerstrom test evaluates the dependence on cigarettes from 0 to 10 (0 indicated a very low dependence and 10 a very strong dependence)
Measured: at inclusion
Proportion of patients with persistent tobacco consumption despite nicotine replacement treatment
Tobacco consumption will be assessed by Fagerström survey and DSM-5 and expired carbon monoxide for patients with nicotine substitutes
Measured: at inclusion
Number of previous tobacco weaning episodes and co-morbid psychiatric disorders
Measured: at inclusion
Number of co-morbid psychiatric disorders
Measured: at inclusion
Factors associated with psychiatric disorders as assessed by Mini International Neuropsychiatric Interview (MINI) test
The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a structured diagnostic interview (40 minutes duration), exploring in a standardized way the main psychiatric disorders of Axis I of the DSM-IV TR (American Psychiatric Association), namely 14 items with a binary result for each specified disorder
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Langerhans Cell HistiocytosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114304
- Sponsor's protocol ID
- APHP210292
- Acronym
- PsyHistio
- Status last verified
- Jul 2021
- First submitted
- 18 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis: an Exploratory Study
- ClinicalTrials.gov ID
- NCT05114304
- Acronym / sponsor ID
- PsyHistio / APHP210292
- Conditions
- Pulmonary Langerhans Cell Histiocytosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 9 Nov 2021 (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.
Pulmonary Langerhans cell histiocytosis (PLCH) is a rare disease, of unknown etiology, that occurs almost exclusively in smokers.The clinical experience suggests a high prevalence of anxiety symptoms and an addictive profile. However, no study to date has precisely investigated the prevalence of co-morbid psychiatric disorders in this population.The aim of the study is to evaluate the prevalence of co-morbid psychiatric disorders in adult PLCH patients.
This study should allow:
- to assess the prevalence of psychiatric disorders co-morbid in PLCH patients
- a targeted and more effective management of patients
- a better response rate to smoking and cannabis weaning, that represents a major goal for these patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Langerhans cell histiocytosis (PLCH) | – | Other: Evaluation of co-morbid psychiatric disordersAdults with pulmonary Langerhans cell histiocytosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with pulmonary Langerhans cell histiocytosis
Key inclusion criteria (3 listed)
- Patients of 18 years of age or older with PLCH diagnosed at adulthood
- Patients affiliated to the French Health Care System
- Informed patients
Key exclusion criteria (3 listed)
- Patient unable to understand the interview (language barrier)
- Patient under guardianship or curatorship
- Patient under AME (French medical help for foreigners)
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 |
|---|---|---|
| Evaluation of co-morbid psychiatric disordersAdded scales : * Mini Internationnal Neuropsychiatric Interview * Fagerström test * DSM-5 Scale Additional dosage : - a urine sample will be taken to evaluate the presence of tobacco and nicotine breakdown products and the presence of various toxics Expired carbon monoxide for patients using nicotine substitutes | Other | Pulmonary Langerhans cell histiocytosis (PLCH) |
Primary outcome
Proportion of patients with at least one of the disorders detailed in the Mini International Neuropsychiatric Interview (MINI) test
Time frame: at inclusion
The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a structured diagnostic interview (40 minutes duration), exploring in a standardized way the main psychiatric disorders of Axis I of the DSM-IV TR (American Psychiatric Association), namely 14 items with a binary result for each specified disorder
6 secondary outcomes
Proportion of patients with at least one comorbid addictive disorder among: tobacco, alcohol, cannabis, benzodiazepines, cocaine, opiates
Time frame: at inclusion
Proportion of patients with active tobacco consumption with or without comorbid psychiatric disorder
Time frame: at inclusion
Proportion of patients with persistent tobacco consumption despite nicotine replacement treatment
Time frame: at inclusion
Number of previous tobacco weaning episodes and co-morbid psychiatric disorders
Time frame: at inclusion
Number of co-morbid psychiatric disorders
Time frame: at inclusion
Factors associated with psychiatric disorders as assessed by Mini International Neuropsychiatric Interview (MINI) test
Time frame: at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Pulmonary Langerhans Cell Histiocytosis, run by Assistance Publique - Hôpitaux de Paris 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 3 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 9 Nov 2021. 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 Abdellatif TAZI (+33142499618, abdellatif.tazi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with at least one of the disorders detailed in the Mini International Neuropsychiatric Interview (MINI) test (time frame: at inclusion). 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 9 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.