Viewing Study NCT05800535


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Ignite Modification Date: 2025-12-25 @ 8:11 PM
Study NCT ID: NCT05800535
Status: RECRUITING
Last Update Posted: 2025-11-21
First Post: 2023-03-24
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: JUMP Prevalence of Sarcopenia and Chemobrain in Post-cancer Patients
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D000084202', 'term': 'Chemotherapy-Related Cognitive Impairment'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2023-03-24', 'studyFirstSubmitQcDate': '2023-03-24', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of patients with physical and neurocognitive impairment', 'timeFrame': 'at least 1 year later after chemical treatments', 'description': 'Number of patients whose medical assessments show altered physical, cognitive or anxiety/dpression activity compared to the measurement in the general population'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post cancer', 'Chemobrain', 'Sarcopenia', 'Medical evaluation'], 'conditions': ['Cancer', 'Sarcopenia']}, 'descriptionModule': {'briefSummary': 'Therapeutic advances in oncology have transformed the prognosis of cancer patients, placing a significant number of them either in a context of recovery or in prolonged remission close to a chronic disease. Thus, the reconquest of a life after cancer becomes possible but raises many challenges for the patient, his entourage, the medical profession and our society. One of the major challenges is the detection and management of treatment side effects for all patients. In addition to the standard organic assessment (glycaemia, creatinine, liver test, blood count), we are mainly interested in muscle deconditioning and cognitive impairment, which are particularly disturbed in these populations. After the evaluation day, patients are referred to the most appropriate structures (Adapted physical activity, sports for health, and rehabilitation at Henry Gabriel Hospital).\n\nJUMP research is part of axis 2 of the 2021-2030 cancer plan: "Limiting sequelae and improving quality of life", through sheets 1 (research) / 6 (access and quality) / 7 (prevention). This leads to the concrete implementation on the territory of adapted care channels in the city: medical structure, physiotherapy, Adapted Physical Activity (APA) structures, associative structures; which makes it possible to develop and strengthen the city-hospital link. Finally, it allows the patient to take ownership and get involved in the project, allowing in the future to make them truly active in they care and to advise and motivate their peers.\n\nThis study is non-interventional, it uses research on data that is already collected as part of conventional care, during the JUMP evaluation day.\n\nThis study allows the investigators to constitute a cohort of patients to study different parameters related to the disease or to the treatments received.\n\nOur main objective in this study is to describe the muscular and neurocognitive impairment of post-cancer patients evaluated as part of the JUMP program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who have been treated for cancer and who have completed the post-cancer assessment day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age : 18 to 74 years\n* localization of the primitive: breast, lung, melanoma, testicle, bladder, kidney, ovary, colon and pancreas, hemopathy\n* patient who benefited from the post-cancer assessment day-\n\nExclusion Criteria:\n\n* Under 18years\n* Over 74 years\n* Patient who did not received any chemical treatment\n* Patient who do not wish to participate'}, 'identificationModule': {'nctId': 'NCT05800535', 'acronym': 'JUMP', 'briefTitle': 'JUMP Prevalence of Sarcopenia and Chemobrain in Post-cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Prevalence of Sarcopenia and Chemobrain in Post-cancer Patients', 'orgStudyIdInfo': {'id': '813'}, 'secondaryIdInfos': [{'id': '69HCL23_0177', 'type': 'OTHER', 'domain': 'HCL'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'JUMP Cohort', 'description': 'This study concerns adults with cancer treated with chemotherapy, radiotherapy, hormonal therapy or immunotherapy, in remission or cured. Patients took part in the dedicated post-cancer assessment day.', 'interventionNames': ['Drug: Study of the adverse effects of long-term oncological treatments', 'Behavioral: Study of the long-term side effects of oncological treatments on the anxiety-depressive and cognitive state of patients']}], 'interventions': [{'name': 'Study of the adverse effects of long-term oncological treatments', 'type': 'DRUG', 'description': 'Cognitive and muscular evaluation of patients who have received oncological treatments, away from the latest treatments to assess their impacts', 'armGroupLabels': ['JUMP Cohort']}, {'name': 'Study of the long-term side effects of oncological treatments on the anxiety-depressive and cognitive state of patients', 'type': 'BEHAVIORAL', 'description': 'Cognitive and anxiety-depressive evaluation of patients who have received oncological treatments, away from the latest treatments to assess their impacts', 'armGroupLabels': ['JUMP Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69310', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cyrille CONFAVREUX, PR', 'role': 'CONTACT', 'email': 'Cyrille.confavreux@chu-lyon.fr', 'phone': '4 78 86 12 31', 'phoneExt': '+33'}], 'facility': 'Service de Rhumatologie, Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'Cyrille CONFAVREUX, MD', 'role': 'CONTACT', 'email': 'Cyrille.confavreux@chu-lyon.fr', 'phone': '+334 78 86 12 31'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}