Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2026-02-11 @ 2:35 AM
Study NCT ID:
NCT05114304
Status:
UNKNOWN
Last Update Posted:
2021-11-09
First Post:
2021-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006646', 'term': 'Histiocytosis, Langerhans-Cell'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-08', 'studyFirstSubmitDate': '2021-10-18', 'studyFirstSubmitQcDate': '2021-11-08', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with at least one of the disorders detailed in the Mini International Neuropsychiatric Interview (MINI) test', 'timeFrame': 'at inclusion', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with at least one comorbid addictive disorder among: tobacco, alcohol, cannabis, benzodiazepines, cocaine, opiates', 'timeFrame': 'at inclusion', 'description': 'Definition and diagnosis of addictive disorder will be assessed with Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)'}, {'measure': 'Proportion of patients with active tobacco consumption with or without comorbid psychiatric disorder', 'timeFrame': 'at inclusion', 'description': '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)'}, {'measure': 'Proportion of patients with persistent tobacco consumption despite nicotine replacement treatment', 'timeFrame': 'at inclusion', 'description': 'Tobacco consumption will be assessed by Fagerström survey and DSM-5 and expired carbon monoxide for patients with nicotine substitutes'}, {'measure': 'Number of previous tobacco weaning episodes and co-morbid psychiatric disorders', 'timeFrame': 'at inclusion'}, {'measure': 'Number of co-morbid psychiatric disorders', 'timeFrame': 'at inclusion'}, {'measure': 'Factors associated with psychiatric disorders as assessed by Mini International Neuropsychiatric Interview (MINI) test', 'timeFrame': 'at inclusion', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Langerhans Cell Histiocytosis']}, 'descriptionModule': {'briefSummary': '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.\n\nThis study should allow:\n\n* to assess the prevalence of psychiatric disorders co-morbid in PLCH patients\n* a targeted and more effective management of patients\n* a better response rate to smoking and cannabis weaning, that represents a major goal for these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with pulmonary Langerhans cell histiocytosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of 18 years of age or older with PLCH diagnosed at adulthood\n* Patients affiliated to the French Health Care System\n* Informed patients\n\nExclusion Criteria:\n\n* Patient unable to understand the interview (language barrier)\n* Patient under guardianship or curatorship\n* Patient under AME (French medical help for foreigners)'}, 'identificationModule': {'nctId': 'NCT05114304', 'acronym': 'PsyHistio', 'briefTitle': 'Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis: an Exploratory Study', 'orgStudyIdInfo': {'id': 'APHP210292'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary Langerhans cell histiocytosis (PLCH)', 'description': 'Adults with pulmonary Langerhans cell histiocytosis', 'interventionNames': ['Other: Evaluation of co-morbid psychiatric disorders']}], 'interventions': [{'name': 'Evaluation of co-morbid psychiatric disorders', 'type': 'OTHER', 'description': 'Added scales :\n\n* Mini Internationnal Neuropsychiatric Interview\n* Fagerström test\n* DSM-5 Scale\n\nAdditional dosage : - a urine sample will be taken to evaluate the presence of tobacco and nicotine breakdown products and the presence of various toxics\n\nExpired carbon monoxide for patients using nicotine substitutes', 'armGroupLabels': ['Pulmonary Langerhans cell histiocytosis (PLCH)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Abdellatif TAZI', 'role': 'CONTACT'}], 'facility': 'Hôpital Saint-Louis, Centre de référence national des histiocytoses, Service de Pneumologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Abdellatif TAZI', 'role': 'CONTACT', 'email': 'abdellatif.tazi@aphp.fr', 'phone': '+33142499618'}, {'name': 'Matthieu Resche-Rigon, Pr', 'role': 'CONTACT', 'email': 'matthieu.resche-rigon@u-paris.fr', 'phone': '+33142499742'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}