Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT05298293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-04-05
First Post:
2022-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-25', 'studyFirstSubmitDate': '2022-03-07', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of events', 'timeFrame': '29 months', 'description': 'The events will be collected (CTCAE V5.0) per patient'}, {'measure': 'Delay of taking care of event', 'timeFrame': '29 months', 'description': 'The period of management of event will be evaluated between the date of the event and the first action realize to manage this event (patient contact, consultation, hospitalization, prescription, etc.) incremented in the source file'}, {'measure': 'Description of emergency entry', 'timeFrame': '29 months', 'description': 'The number of emergency visits (consultation or hospitalization in the suites) per arm'}, {'measure': 'Description of hospitalisations', 'timeFrame': '29 months', 'description': 'The number and average length of stay of hospitalizations per patient and per arm'}, {'measure': 'Description of dose/intensity of RCHOP regimen', 'timeFrame': '29 months', 'description': 'The dose of treatment received compared to the theoretical dose will assess the dose / intensity'}, {'measure': 'Description of treatment interruptions', 'timeFrame': '29 months', 'description': 'The number of patients having had a treatment interruption will be recorded out of the total number of patients'}, {'measure': 'Description of the quality of life', 'timeFrame': '29 months', 'description': 'Quality of life will be evaluated by the Quality of Life Questionnaire-C30 (QLQ-C30). QLQ-C30 is a generic questionnaire for cancer patients. Score will be calculated according to EORTC guidelines. The scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. QoL with QLQ-C30 will be evaluated before start of treatment, at the 3rd cycle, 6th and 8th cycles of treatment and then at 12 and 24 months. Score will be calculated according to EORTC guidelines'}, {'measure': 'Description of anxiety', 'timeFrame': '29 months', 'description': 'Anxiety will be evaluated by the State-Trait Anxiety Inventory Form Y (STAI-Y scale). STAI-Y is a specific questionnaire for which reflects the current emotional state (STAI-form Y-A) which makes it possible to assess the nervousness and anxiety of the patient. The scores range from 20 to 80; Higher score is worse.\n\nSTAI-Y will be evaluated before start of treatment, at the 3rd cycle, 6th and 8th cycles of treatment and then at 12 and 24 months.'}, {'measure': "Description of patient's satisfaction with specific questionnaire dedicated to the use of the web-application", 'timeFrame': '29 months', 'description': 'Patient satisfaction will be evaluated by a specific self-evaluation (specific questionnaire dedicated to the use of the web-application) at the end of treatment, 12th and 24th months follow-up visits. The scores range from 14 to 70; Higher score is better.'}, {'measure': 'Overall survival', 'timeFrame': '29 months', 'description': 'Overall survival will be calculated from the date of randomization to the date of death due to any cause or the date last known to be alive if patient is censored'}, {'measure': 'Progression Free survival', 'timeFrame': '29 months', 'description': 'Progression Free survival will be calculated from the date of randomization to the date of first progression of disease based on Investigator assessment per Lugano classification or the date of death or censored at the date of the last valid tumor assessment'}, {'measure': 'Event-free survival', 'timeFrame': '29 months', 'description': 'Event-free survival will be defined as the time between the date of treatment initiation and the date of the first event (relapse, death, unplanned hospitalizations) demonstrated or the date of death if the patient died or the date of the last news if the patient is censored,'}, {'measure': 'Description of health care team satisfaction by a specific questionnaire dedicated to the use of the web-application', 'timeFrame': '29 months', 'description': 'Health care team satisfaction will be evaluated by a specific questionnaire (specific questionnaire dedicated to the use of the web-application) at the 6th and 12th of use of application. The scores range from 8 to 33; Higher score is worse.'}, {'measure': 'Description of face-to-face consultations', 'timeFrame': '29 months', 'description': 'In the application arm the number of face-to-face consultations triggered by an alert'}, {'measure': 'Description of teleconsultations', 'timeFrame': '29 months', 'description': 'In the application arm the number of teleconsultations triggered by an alert'}, {'measure': 'Description of drug prescriptions', 'timeFrame': '29 months', 'description': 'In the application arm the number of drug prescription triggered by an alert'}, {'measure': 'Description of nursing prescription', 'timeFrame': '29 months', 'description': 'In the application arm the number of nursing prescription triggered by an alert'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ONCOLAXY web-application', 'electronic Patient Reported Outcomes'], 'conditions': ['Diffuse Large B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'Diffuse large B cell lymphoma is the most common malignant lymphoid hemopathy. More than half of the patients will be cured with an RCHOP-type immunochemotherapy protocol (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone). Monitoring of adverse effects, risk of relapse and quality of life are essential in overall management. Patients are the best candidates to report them. Managing these events should improve quality of life and reduce costs. The aim of this study is to assess the feasibility of monitoring these events by a web application (Oncolaxy©) and to compare it with a control population in the context of a randomized pilot study including 80 patients per arm with diffuse large cell B lymphoma in first-line treatment with R-CHOP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient with untreated large B cell lymphoma requiring a first line treatment by RCHOP or R-mini-CHOP\n2. Patient aged 18 years or older at the time of signing Informed Consent Form\n3. Additional Intrathecal or/and intravenous treatment with Methotrexate allowed, if indicated\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status \\< 3\n5. Patient with internet access (or has someone at home who can help send patients' symptoms or complete the form)\n6. Patient enrolled in social security\n7. Patient has given his written consent ahead of any specific protocol procedure\n\nExclusion Criteria:\n\n1. Patient with symptomatic brain metastases,\n2. Patient deprived of their liberty, under guardianship or trusteeship\n3. Patient is being treated for another cancer and has not been cured\n4. Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol\n5. Patient cannot submit to the protocol for psychological, social, familial or geographical reasons\n6. Patient is pregnant or breastfeeding"}, 'identificationModule': {'nctId': 'NCT05298293', 'acronym': 'EMILY', 'briefTitle': 'Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma', 'organization': {'class': 'OTHER', 'fullName': 'Weprom'}, 'officialTitle': 'Evaluation of a Web Application on Event Reporting for Patients With B Lymphoma on First Line Treatment', 'orgStudyIdInfo': {'id': 'WP-2022-01'}, 'secondaryIdInfos': [{'id': '2021-A02957-34', 'type': 'OTHER', 'domain': 'French Health Products Safety Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ONCOLAXY follow-up', 'description': 'patients will make a regular assessment of symptoms via an electronic questionnaire', 'interventionNames': ['Device: ONCOLAXY Follow-up']}, {'type': 'NO_INTERVENTION', 'label': 'Standard follow-up', 'description': 'patients will have the standard follow-up'}], 'interventions': [{'name': 'ONCOLAXY Follow-up', 'type': 'DEVICE', 'description': 'The operation of Oncolaxy© is based on the principle of e-PRO (electronic patient reported outcome) which is able to assess the symptoms declared by patients treated for cancer, to detect an evolution, a recurrence or the toxicity of a therapy. Alerts are sent to the healthcare team if the algorithm detects suspicious symptoms or worsening of these symptoms.\n\nOncolaxy© records symptoms using an electronic questionnaire that allows them to be graded. Questionnaires are sent out on a regular basis. The algorithm analyzes the responses and processes them taking into account the score of the response and its evolution over time. The combination of the results makes it possible to send information to the healthcare teams in charge of the patient that will alert them, enlighten them and help them guide their decisions which remain under their sole control. The summary of the results can be viewed at any time on a dashboard.', 'armGroupLabels': ['ONCOLAXY follow-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33077', 'city': 'Bordeaux', 'country': 'France', 'contacts': [{'name': 'Olivier FITOUSSI, MD', 'role': 'CONTACT', 'email': 'o.fitoussi@bordeauxnord.com'}, {'name': 'Olivier FITOUSSI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Polyclinique Bordeaux Nord Aquitaine', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'contacts': [{'name': 'Marielle LE GOFF, MD', 'role': 'CONTACT', 'email': 'm.legoff@ilcgroupe.fr'}, {'name': 'Marielle LE GOFF, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Victor Hugo/Centre Jean Bernard/ILC', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '44200', 'city': 'Nantes', 'country': 'France', 'contacts': [{'name': 'Katell LE DÛ, MD', 'role': 'CONTACT', 'email': 'dr.ledu@groupeconfluent.fr'}, {'name': 'Katell LE DÛ, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Privée du Confluent', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44600', 'city': 'Saint-Nazaire', 'country': 'France', 'contacts': [{'name': 'Elsa LESTANG, MD', 'role': 'CONTACT', 'email': 'e.lestang@ch-saintnazaire.fr'}, {'name': 'Elsa LESTANG, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de St Nazaire', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Frédéric MALOISEL, MD', 'role': 'CONTACT', 'email': 'fmaloisel@solcrr.org'}, {'name': 'Frédéric MALOISEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre de radiothérapie de Robertsau', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Magali BALAVOINE', 'role': 'CONTACT', 'email': 'm.balavoine@ilcgroupe.fr', 'phone': '2 41 68 29 70', 'phoneExt': '+33'}, {'name': 'Katell LE DÛ, MD', 'role': 'CONTACT', 'email': 'dr.ledu@groupeconfluent.fr'}], 'overallOfficials': [{'name': 'Katell LE DÛ, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Privée du Confluent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weprom', 'class': 'OTHER'}, 'collaborators': [{'name': 'Resilience', 'class': 'INDUSTRY'}, {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}