Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT07096258
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EMPATHY NSCLC: European Registry for Plasma-Based Molecular Profiling in Advanced NSCLC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Actionable biomarkers', 'timeFrame': 'At baseline', 'description': 'Proportion of patients with successful molecular profiling and detectable actionable biomarkers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NSCLC (Advanced Non-small Cell Lung Cancer)']}, 'descriptionModule': {'briefSummary': 'The goal of this registry is to capture real-world data from plasma- and tissue-based molecular profiling, treatments, outcomes and patient-reported outcomes from patients with advanced or metastatic non-small cell lung cancer (NSCLC). The main objective of the study is to better understand the real-world clinical practice of the use and utility of molecular tumour profiling, the choice of treatment, and the outcome after such molecular profiling and treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer Hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally advanced or metastatic, unresectable NSCLC, stages IIIB/C or IV, who have not previously been treated for this advanced disease.\n* Intention-to-initiate first-line tumour therapy for this advanced disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* At least 18 years of age on the day of signing informed consent, and capable of signing informed consent.\n\nExclusion Criteria:\n\n* Any known non-cutaneous malignancy (except for this NSCLC and early-stage non-invasive cervical cancer) that has occurred within 5 years prior to enrolment.'}, 'identificationModule': {'nctId': 'NCT07096258', 'acronym': 'EMPATHY NSCLC', 'briefTitle': 'EMPATHY NSCLC: European Registry for Plasma-Based Molecular Profiling in Advanced NSCLC Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hedera Dx SA'}, 'officialTitle': 'A Patient Registry Collecting the Clinical and Molecular Profiling Data of Patients With Locally Advanced and/or Metastatic, Unresectable, Stages IIIB/C or IV Non-small Cell Lung Cancer (NSCLC), Who Have Not Previously Been Treated for This Advanced Disease and Are Therefore Considered as Patients Receiving First-line Therapy.', 'orgStudyIdInfo': {'id': 'EMPATHY NSCLC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advanced NSCLC patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54519', 'city': 'Nancy', 'state': 'Lorraine', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Université de Lorraine', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'University of Naples "Federico II"', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '28007', 'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'facility': 'General Universitario Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '1211', 'city': 'Geneva', 'state': 'Canton of Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Hôpitaux Universitaires Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'Dr. Christian Meisel, MD PhD', 'role': 'CONTACT', 'email': 'HederaDxStudies@hederadx.com', 'phone': '+41 21 588 16 54'}], 'overallOfficials': [{'name': 'Dr. Christian Meisel, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hedera Dx'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Clinical investigators may request appropriate access to individual de-identified data via the EMPATHY NSCLC Steering Committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hedera Dx SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}