Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT06923618
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cancer of the Lung And SeneScencE - Prospective Cohort 1
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 385}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2032-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-02-17', 'studyFirstSubmitQcDate': '2025-04-04', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unplanned hospitalizations within 12 months', 'timeFrame': '12 months post surgery', 'description': 'Number of unplanned hospitalizations within 12 months'}], 'secondaryOutcomes': [{'measure': 'Mortality (all-cause) and cause-specific', 'timeFrame': 'Month 12 and Month 60 post surgery', 'description': 'Number of death (all-cause) and cause-specific at Month12 and Month 60'}, {'measure': 'Surgical Complications', 'timeFrame': 'Month 3 and Month 6 post surgery', 'description': 'Scores on the Clavien-Dindo Scale at Month 3 and Month 6'}, {'measure': 'Major Toxicities', 'timeFrame': 'Month 3 and Month 6 post surgery', 'description': 'Scores on the NCI-PRO-CTCA (National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) scale (Lickert scale with 5 levels/item) at Month 3 . A higher score means worse outcome.'}, {'measure': 'Quality of Life Core 30', 'timeFrame': 'Month 6 and Month 12 post surgery.', 'description': 'Scores on the Quality of Life (QLQ) patients self-questionnaires Core 30 (0-100 points) at Month 6 and Month 12. A higher score means worse outcome.'}, {'measure': 'Quality of Life Lung Cancer 13', 'timeFrame': 'Month 6 and Month 12 post surgery', 'description': 'Scores on the Quality of Life (QLQ) patients self-questionnaires Lung Cancer 13 (0-100 points) at Month 6 and Month 12. A higher score means worse outcome.'}, {'measure': 'Quality of Life Elderly 14', 'timeFrame': 'Month 6 and Month 12 post surgery', 'description': 'Scores on the Quality of Life (QLQ) patients self-questionnaires Elderly 14 (0-100 points) at Month 6 and Month 12. A higher score means worse outcome.'}, {'measure': 'Disease-free survival', 'timeFrame': 'Month 3, Month 12 and Month 60 post surgery', 'description': 'Disease-free survival on imaging (CT scan) at Month 3, Month 6, Month 12 and Month 60'}, {'measure': 'Geriatric Parameters G-CODE', 'timeFrame': 'Month 3 and Month 6 post surgery', 'description': 'Score on Geriatric-COre Data sEt (G-CODE) (0-17) at Month 3 and Month 6. A higher score means better outcome.'}, {'measure': 'Geriatric Parameters Hand grip', 'timeFrame': 'Month 3 and Month 6 post surgery', 'description': 'Scores on Hand grip (kg) at Month 3 and Month 6. A higher score means better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Small Cell Lung Cancer', 'Aging biomarkers'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The main objective is to identify and assess the predictive value of ageing and senescence biomarkers (methylome, telomeres, inflammageing) and senescent cells in tissues to improve prognosis assessment older patients with locally or locally-advanced Non-Small Cell Lung Cancer (NSCLC).', 'detailedDescription': "Geriatric assessment allows oncologists to stratify older cancer patients into risk categories (fit, vulnerable and frail) but few patients benefit from it. Yet, they do not evaluate physiological reserves when oncologists are in dire need of quantitative tools accounting for age-related changes. This decade has witnessed the remarkable power of multiple tools (epigenetics, telomere integrity, cellular and immunosenescence) to estimate an individual's age. These tools hold the potential for routine implementation in the clinic and to be combined with existing tests. The main objective is to identify and assess the predictive value of ageing and senescence biomarkers (methylome, telomeres, inflammageing) and senescent cells in tissues to improve to improve prognosis assessment in older patients with locally or locally-advanced Non-Small Cell Lung Cancer (NSCLC).\n\nThe ambition of this study is to refine the prognosis assessment and optimize decision-making process, better anticipate adverse-events and unplanned hospitalization and better manage and care high risk patients of early death, unplanned hospitalization, major complication or toxicities and altered quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 70 years and over\n* Local or locally advanced (Clinic stage I-IIIA) NSCLC (clinically (or radiologically) suspected or histologically proven)\n* Surgical Curative Intent\n* Signed informed Consent (or signed by the curator or tutorship)\n* Affiliated to social security administrative care service\n\nExclusion Criteria:\n\n* Synchronous cancer (histologically proven or strongly suspected non-lung cancer in the 6 months prior to inclusion (excluding basal cell cancer and prostate cancer with local treatment (radiotherapy or surgery) or active surveillance without systemic treatment (chemotherapy, hormone therapy)).\n* Subject deprived of liberty by judicial or administrative decision or patient under guardianship\n* Subject unable to understand the purpose and conditions of the study and unable to give consent'}, 'identificationModule': {'nctId': 'NCT06923618', 'acronym': 'CLASSE-P1', 'briefTitle': 'Cancer of the Lung And SeneScencE - Prospective Cohort 1', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Identification of Aging Biomarkers for Better Tailoring of Cancer Treatment in Older Patients With Lung Cancer: a Multicenter Clinico-biological Cohort Study', 'orgStudyIdInfo': {'id': 'APHP241246'}, 'secondaryIdInfos': [{'id': 'ID-RCB Number', 'type': 'OTHER', 'domain': '2024-A02393-44'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood samples', 'type': 'BIOLOGICAL', 'description': 'Blood samples (5 ml) during surgery or within 3 days before.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florence CANOUÏ-POITRINE, PhD', 'role': 'CONTACT', 'email': 'florence.canoui-poitrine@aphp.fr', 'phone': '01 49 81 36 74', 'phoneExt': '+33'}], 'facility': 'Henri Mondor Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Florence CANOUÏ-POITRINE, PhD', 'role': 'CONTACT', 'email': 'florence.canoui-poitrine@aphp.fr', 'phone': '01 49 81 36 74', 'phoneExt': '+33'}, {'name': 'Adèle BELLINO, Project advisor', 'role': 'CONTACT', 'email': 'adele.bellino@aphp.fr', 'phone': '01 71 76 07 57', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Florence CANOUÏ-POITRINE, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'ARC Foundation and Inserm', 'class': 'UNKNOWN'}, {'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}