Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-30 @ 4:54 AM
Study NCT ID:
NCT05701150
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2023-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'tissue samples collected in clinical routine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '36 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2023-01-18', 'studyFirstSubmitQcDate': '2023-01-18', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Molecular tumorboard utilization', 'timeFrame': '3 years', 'description': "Proportion of patients who's case was discussed in a Molecular tumorboard"}, {'measure': 'Treatment reality after NGS analysis', 'timeFrame': '3 years', 'description': 'Proportion of patients who received at least one targeted therapy based on NGS results, who exclusively received therapies other than targeted therapies based on NGS results or who did not receive any therapy'}, {'measure': 'NGS', 'timeFrame': '3 years', 'description': 'Genomic alterations identified by multi-gene NGS panels'}, {'measure': 'Molecular tumorboard', 'timeFrame': '3 years', 'description': 'Descriptive analysis of MTB-based therapy recommendations, their implementation rate and reasons for non-implementation'}, {'measure': 'Overall response rate', 'timeFrame': '3 years', 'description': 'Overall response rate of targeted therapy based on NGS results'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '3 years', 'description': 'Progression-free survival from start of targeted therapy based on NGS results'}, {'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'Overall survival from start of targeted therapy based on NGS results'}, {'measure': 'PFS ratio', 'timeFrame': '3 years', 'description': 'PFS interval associated with targeted therapy(ies) administered after NGS analysis divided by the time to progression (TTP) interval associated with the last prior treatment(s)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'National, retro- and prospective, observational, multicenter clinical research platform to connect clinical and genomic data of patients with advanced (locally advanced, inoperable, or metastatic) solid tumors (excluding NSCLC, SCLC, and mesothelioma) with results from multi-gene next-generation sequencing (NGS) panels (\\>30 genes)', 'detailedDescription': 'The AIO-BNHO CONNECT research platform is a clinic-genomic database collecting data on NGS results and corresponding clinical outcomes in patients with advanced solid tumors (excluding NSCLC, SCLC, and mesothelioma). Data of deceased patients will be included. The platform will provide insight into the current state of precision oncology in Germany by compiling real-world data encompassing a broad spectrum of care providers including but not limited to practice-based oncologists, community hospitals, and university hospitals. The platform also comprises a decentral tissue repository with clinically annotated tumor specimens retrieved within routine clinical care that can be used in future collaborative research projects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with advanced (locally advanced, inoperable, or metastatic) solid tumors (excluding NSCLC, SCLC, and mesothelioma) ineligible for curative treatment and with results available from multi-gene next-generation sequencing (NGS) panels (\\>30 genes)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of advanced (i.e., locally advanced, inoperable, or metastatic) solid tumor, ineligible for curative surgery and/or curative systemic therapy\n* Available results of commercial or non-commercial RNA- and/or DNA-based multi-gene NGS panels with \\>30 genes analyzed; for non-commercial panels a list of all tested genes and multiple gene biomarkers (e.g., tumor mutational burden (TMB), microsatellite status) must be provided\n* Age ≥ 18 years\n* Signed and dated informed consent form (not applicable for inclusion of deceased patients)\n\nExclusion Criteria:\n\n* Diagnosis of NSCLC/SCLC (C34) or mesothelioma (C45)\n* NGS results older than two years at the date of patient inclusion'}, 'identificationModule': {'nctId': 'NCT05701150', 'acronym': 'CONNECT', 'briefTitle': 'AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT', 'organization': {'class': 'OTHER', 'fullName': 'AIO-Studien-gGmbH'}, 'officialTitle': 'AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT', 'orgStudyIdInfo': {'id': 'AIO-TF-0122'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MIN Data Set', 'description': 'Patients who did not receive a targeted therapy based on NGS results (outside of a clinical trial)', 'interventionNames': ['Other: Minimal documentation', 'Other: Extended documentation']}, {'label': 'EXT Data Set', 'description': 'Patients who received a targeted therapy based on NGS results (outside of a clinical trial)', 'interventionNames': ['Other: Extended documentation']}], 'interventions': [{'name': 'Minimal documentation', 'type': 'OTHER', 'description': 'Minimal data documentation only of patients without targeted therapy based on NGS results', 'armGroupLabels': ['MIN Data Set']}, {'name': 'Extended documentation', 'type': 'OTHER', 'description': 'Extended data documentation of patients with targeted therapy based on NGS results', 'armGroupLabels': ['EXT Data Set', 'MIN Data Set']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79110', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Matthias Zaiss, Dr. med.', 'role': 'CONTACT'}], 'facility': 'Praxis für interdisziplinäre Onkologie & Hämatologie', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sonja Loges, Prof. Dr. Dr. med.', 'role': 'CONTACT', 'email': 'Sonja.Loges@medma.uni-heidelberg.de', 'phone': '+49 621 383', 'phoneExt': '1757'}], 'facility': 'Medizinische Fakultät Mannheim der Universität Heidelberg', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '81377', 'city': 'München', 'state': 'Bavaria', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Benedikt Westphalen, Dr. med.', 'role': 'CONTACT', 'email': 'christoph_benedikt.westphalen@med.uni-muenchen.de', 'phone': '+49 89 4400', 'phoneExt': '75250'}], 'facility': 'Klinikum der Universität München', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}], 'centralContacts': [{'name': 'Marc Fischer', 'role': 'CONTACT', 'email': 'marc.fischer@aio-studien-ggmbh.de', 'phone': '+49 30-8145344', 'phoneExt': '44'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AIO-Studien-gGmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company', 'class': 'INDUSTRY'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Janssen-Cilag G.m.b.H', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}