Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT02928003
Status:
COMPLETED
Last Update Posted:
2019-08-15
First Post:
2016-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Neuropathic Pain After Lung Surgery: Prevalence and Predictive Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}], 'ancestors': [{'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2016-10-05', 'studyFirstSubmitQcDate': '2016-10-06', 'lastUpdatePostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with chronic pain 4 months after surgery', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung surgery'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. Surgical approach as well as other factors (genetic, psychological) could have a major and independent role in the development of the post operative pain.The main objective of this study is to identify genetic and psychological profile (cognitive and emotional) of patients who develop chronic pain after lung surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing lung resection surgery.\n* 18 years and older (without superior limit);\n* Affiliated to french "securité sociale"\n\nExclusion Criteria:\n\n* Emergency procedure\n* litigation or search for compensation;\n* Previous intervention in the same region;\n* Peripheral neurological pathology (polyneuropathy) or central (brain damage, multiple sclerosis …) that may interfere with the evaluation of the post-operative pain\n* Participation in another biomedical research protocol if there is an incompatibility with the present protocol.\n* mental disability\n* vulnerable person within the meaning of French law,\n* poor understanding of French.'}, 'identificationModule': {'nctId': 'NCT02928003', 'acronym': 'DOLORPOUMON', 'briefTitle': 'Chronic Neuropathic Pain After Lung Surgery: Prevalence and Predictive Factors', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Chronic Neuropathic Pain After Lung Surgery: Prevalence and Predictive Factors', 'orgStudyIdInfo': {'id': '2015/35'}, 'secondaryIdInfos': [{'id': '2016-A00045-46', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lung Surgery', 'interventionNames': ['Procedure: Lung surgery']}], 'interventions': [{'name': 'Lung surgery', 'type': 'PROCEDURE', 'description': 'Genetic analysis and questionnaires', 'armGroupLabels': ['Lung Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '750014', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Mireille Michel-Cherqui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Foch'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}