Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT05583318
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2022-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Living Conditions After Non-Hodgkin's Lymphoma in France
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1570}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2022-10-13', 'studyFirstSubmitQcDate': '2022-10-13', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'December 2022', 'description': 'Update of vital status (part 1)'}, {'measure': 'Generic SF-12 questionnaire', 'timeFrame': 'October 2024', 'description': 'Mesure of the quality of life (part 2)'}, {'measure': 'Specific QLQ-C30 questionnaire', 'timeFrame': 'October 2024', 'description': 'Mesure of the quality of life (part 2)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Non-hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': "This is an innovative project, allowing to study for the first time the long-term living conditions of patients after diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) from population data in France. Patients will be selected from the three specialized hematology registries in France: Côte-d'Or, Gironde and Basse-Normandie.\n\nThis is also one of the first studies to look at epidemiological indicators of net survival after diagnosis of follicular lymphoma and diffuse large B-cell lymphoma, adjusted for clinical factors such as disease stage, therapeutic management, and comorbidities, apart from the standard adjustment factors of age, sex, and time of diagnosis in real life. In addition, the proportion of cured patients will be estimated.\n\nFor component 1, this will be the survival analysis on the initial data. For part 2, questionnaires will be sent out followed by a follow-up if necessary one month after the mailing. There is no physical interview nor any specific biological or imaging examination."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with non-Hodgkin's lymphoma", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis period 2010-2018, according to the 2008 WHO ICD-O-3 classification, from the hematological malignancy registries of Côte-d'Or, Gironde, Basse-Normandie\n* Patients with a diagnosis of follicular lymphoma (9690/3, 9691/3, 9695/3, 9698/3, 9597/3)\n* Patients with a diagnosis of diffuse large B-cell lymphoma (9678/3, 9679/3, 9680/3, 9684/3, 9688/3, 9712/3, 9735/3, 9737/3, 9738/3)\n* For Part 2: Individuals alive at the date of vital status update\n\nNon-inclusion criteria:\n\n* Other forms of malignant hemopathies at diagnosis,\n* Minors.\n\nExclusion Criteria:\n\n* Person under a legal protection measure (curatorship, guardianship)\n* Person under a legal protection measure (guardianship, tutorship)\n* Pregnant, parturient or breastfeeding women\n* Major incapable or unable to express his consent\n* Person who did not return the questionnaires following the 1-month follow-up, or patient who expressed refusal to participate."}, 'identificationModule': {'nctId': 'NCT05583318', 'acronym': 'LymphoVie 2', 'briefTitle': "Living Conditions After Non-Hodgkin's Lymphoma in France", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': "Living Conditions After Non-Hodgkin's Lymphoma in France", 'orgStudyIdInfo': {'id': 'MAYNADIE 2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Part 1: Patients diagnosed with non-Hodgkin's lymphoma", 'description': "Diagnosis period 2010-2018, from the hematological malignancy registries of Côte-d'Or, Gironde, Basse-Normandie", 'interventionNames': ['Other: Data collection']}, {'label': "Part 2: Patients diagnosed with live non-Hodgkin's lymphoma after vital status update", 'description': 'Update of vital status in December 2022', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Data from hematological malignancy registries', 'armGroupLabels': ["Part 1: Patients diagnosed with non-Hodgkin's lymphoma"]}, {'name': 'Questionnaires', 'type': 'OTHER', 'description': '9 questionnaires were sent out:\n\n1. QLQ-C30 and SF-12 Quality of Life Questionnaire.\n2. Oral quality of life questionnaire QLQ-OH15\n3. Sexuality questionnaire SHQ-C22\n4. Anxiety and depression questionnaire HADS,\n5. Rosenberg Self-Esteem Questionnaire\n6. RNLI Reintegration to Normal Life Questionnaire\n7. Social Support Questionnaire SSQ6,\n8. Socio-economic status questionnaire EPICES,\n9. Complementary questionnaire collecting data on socio-professional status.', 'armGroupLabels': ["Part 2: Patients diagnosed with live non-Hodgkin's lymphoma after vital status update"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}