Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT06180005
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence and Characterization of Drivers Oncogenes in the Population With Lung Cancer Afferents to the Cancer Institute in Aviano (IN.ON.D.)
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': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2039-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2023-12-21', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-01-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assess the feasibility of developing Neural Language Processing (NLP) algorithms for the extraction of structured data from unstructured texts and verify the reliability of the results', 'timeFrame': 'up to 15 years', 'description': 'Key information to identify in the unstructured text will be defined and frequency of correct identification will be reported'}], 'primaryOutcomes': [{'measure': 'To evaluate the frequency of patients with oncogene addiction in a consecutive series of patients afferent to the CRO with NSCLC.', 'timeFrame': 'up to 15 years', 'description': 'Frequency of patients carriers of one of the mutations among EGFR, ALK, RET, KRAS, BRAF, Her2, ROS1, MET'}], 'secondaryOutcomes': [{'measure': 'Frequency of mutations according to tumor histotype (squamous and nonsquamous)', 'timeFrame': 'up to 15 years', 'description': 'Frequency of selected mutations according to tumor histotype (squamous and nonsquamous)'}, {'measure': 'Evaluate trend of mutations over time', 'timeFrame': 'up to 15 years', 'description': 'Frequency of patient carrying one target mutation in each study year'}, {'measure': 'Compare PFS in new patients with and without oncogene addiction', 'timeFrame': 'up to 15 years', 'description': 'Difference in PFS probability between patients with and without oncogene addiction (carrier of a targetable mutation). PFS will be defined as the time between enrollment in the study (first visit) and progression or death from any cause, whichever happens first, or the end of the study'}, {'measure': 'Compare OS in new patients with and without oncogene addiction', 'timeFrame': 'up to 15 years', 'description': 'Difference in OS probability between patients with and without oncogene addiction (carrier of a targetable mutation). OS will be defined as time between enrollment in the study (first visit) and death from any cause or the end of the study'}, {'measure': 'Assess OS in different mutation types, stratifying by histotype', 'timeFrame': 'up to 15 years', 'description': 'Describe OS probability in different mutation types, stratifying by histotype. OS will be defined as time between enrollment in the study (first visit) and death from any cause or the end of the study'}, {'measure': 'Assess PFS in different mutation types, stratifying by histotype', 'timeFrame': 'up to 15 years', 'description': 'Describe PFS probability in different mutation types, stratifying by histotype. PFS will be defined as the time between enrollment in the study (first visit) and progression or death from any cause, whichever happens first, or the end of the study'}, {'measure': 'Assess the frequency of different types of molecular alterations and possible new target alterations', 'timeFrame': 'up to 15 years', 'description': 'Frequency of different types of targetable molecular alterations, including possible new target alterations emerging during study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'According to an analysis by Memorial Sloan Kettering Cancer Center patients who receive a target therapy having an oncogenic driver mutation live longer than those who do not receive it. In addition to that, therapies guided by analysis on mutations identified in ct-DNA had a favorable impact, allowing longer survival. All this suggests that the presence of a therapeutically targetable oncogene (oncogene addicted) allows target therapy, resulting in a longer life expectancy. The main objective of this study is to evaluate the frequency of patients with oncogene addiction in a consecutive series of patients with NSCLC afferent to the CRO. Oncogene addiction is defined as being carriers of one of the mutations among EGFR, ALK, RET, KRAS, BRAF, Her2, ROS1, MET or other mutations that become therapeutic targets under investigation.', 'detailedDescription': 'According to an analysis by Memorial Sloan Kettering Cancer Center patients who receive a target therapy having an oncogenic driver mutation live longer than those who do not receive it. In addition to that, therapies guided by analysis on mutations identified in ct-DNA had a favorable impact, allowing longer survival. All this suggests that the presence of a therapeutically targetable oncogene (oncogene addicted) allows target therapy, resulting in a longer life expectancy. The main objective of this study is to evaluate the frequency of patients with oncogene addiction in a consecutive series of patients with NSCLC afferent to the CRO. Oncogene addiction is defined as being carriers of one of the mutations among EGFR, ALK, RET, KRAS, BRAF, Her2, ROS1, MET or other mutations that become therapeutic targets under investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population consists of patients with NSCLC who are afferent to the CRO. All patients who give their consent to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First visit or first admission to CRO occurred in the period from September 2023 to September 2028\n* Diagnosis of NSCLC any stage\n\nExclusion Criteria:\n\n\\- Diagnosis of tumor not of certain lung origin (uncertain origin)'}, 'identificationModule': {'nctId': 'NCT06180005', 'acronym': 'INOND', 'briefTitle': 'Incidence and Characterization of Drivers Oncogenes in the Population With Lung Cancer Afferents to the Cancer Institute in Aviano (IN.ON.D.)', 'organization': {'class': 'OTHER', 'fullName': 'Centro di Riferimento Oncologico - Aviano'}, 'officialTitle': 'Incidence and Characterization of Drivers Oncogenes in the Population With Lung Cancer Afferents to the Cancer Institute in Aviano (IN.ON.D)', 'orgStudyIdInfo': {'id': 'CRO-2023-38'}}, 'contactsLocationsModule': {'locations': [{'zip': '33081', 'city': 'Aviano', 'state': 'Pordenone', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Del Conte, MD', 'role': 'CONTACT', 'email': 'alessandro.delconte@cro.it', 'phone': '0434 399464'}, {'name': 'Alessandro Del Conte, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}], 'centralContacts': [{'name': 'Alessandro Del Conte, MD', 'role': 'CONTACT', 'email': 'alessandro.delconte@cro.it', 'phone': '0434 399464'}], 'overallOfficials': [{'name': 'Alessandro Del Conte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS'}, {'name': 'Alessandra Bearz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro di Riferimento Oncologico - Aviano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}