Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT03926260
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2019-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2019-04-16', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biological response at week 3', 'timeFrame': "week 3 after patient's recruitment date (baseline)", 'description': 'Changes of the amount of ctDNA between baseline and week 3 will make it possible to determine the biological response: increase, stability or decrease in ctDNA.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (radiological assessment) and biological response at week 3.', 'timeFrame': 'week 3 after baseline', 'description': 'Radiological assessment, based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1, will be: complete response, partial response, progression or stabilization. Biological response will be: increase, stability or decrease in ctDNA.'}, {'measure': 'biological progression and radiological progression', 'timeFrame': 'progression', 'description': 'Biological progression will be: increase in ctDNA - Radiological progression will be defined according to RECIST criteria v1.1 will be: progression'}, {'measure': 'biological response and radiological response', 'timeFrame': 'progression', 'description': 'Biological response will be: increase, stability or decrease in ctDNA and Radiological response will be defined according to RECIST criteria v1.1 will be: complete or partial response'}, {'measure': 'Biological response and progression-free survival (radiological assessment) according to the therapeutic management: targeted therapies, immunotherapy, chemotherapy', 'timeFrame': 'week 3 after baseline', 'description': 'Radiological assessment, based on RECIST criteria v1.1, will be: complete response or partial response. Biological response will be: increase, stability or decrease in ctDNA.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '40075630', 'type': 'BACKGROUND', 'citation': 'Herbreteau G, Marcq M, Sauzay C, Carpentier M, Pierre-Noel E, Pons-Tostivint E, Vallee A, Theoleyre S, Bizieux A, Bennouna J, Denis MG. Absolute Quantification of Nucleotide Variants in Cell-Free DNA via Quantitative NGS: Clinical Application in Non-Small Cell Lung Cancer Patients. Cancers (Basel). 2025 Feb 25;17(5):783. doi: 10.3390/cancers17050783.'}]}, 'descriptionModule': {'briefSummary': "In patients with locally advanced or metastatic tumors, first-line therapeutic management is based on the use of targeted therapies (EGFR, BRAF ALK and ROS1 inhibitors), immunotherapies (anti-PD1/ anti-PDL1-antibodies or chemotherapy.\n\nDespite patient selection based on histo-pathological and molecular criteria, not all patients respond to treatment. There are currently no markers to definitively guarantee a patient's response.\n\nAn alternative is to identify early patient response to treatment. The investigator hypothesize that change in circulating tumor DNA concentration (ctDNA) allow to early identify patients' therapeutic response (and non-response) of patients, regardless of the type of treatment used in the first line setting.", 'detailedDescription': 'The primary objective is to determine whether early evolution (between baseline and week 3) of circulating tumor DNA concentration predicts the radiological response to first-line treatment of advanced or metastatic NSCLC patients, regardless of treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic or locally advanced non-small cell lung cancer (stage III or IV)\n* At least one measurable target according to RECIST criteria\n* Identification of at least one molecular alteration in the tissue sample analyzed in the framework of patient management\n* Performance Status 0 to 2\n* Affiliated to a social security system\n* Patient who can be followed under the protocol\n* Patient agreed to participate in the study and gave his/her express consent\n\nExclusion Criteria:\n\n* Minor\n* Small cell or mixed bronchial cancer\n* Radiotherapy (except radiotherapy for antalgic purposes) during the last 7 days\n* Patient who has already started a first line of treatment\n* Patient already included in an interventional research protocol that may have an impact on the results of the ELUCID study\n* History of cancer (with the exception of non-melanoma skin, cervical cancer in situ, adequately treated) with sign of illness during the last 5 years\n* Patient which, does present a substantial risk of recurrence.\n* Major under guardianship, curators or deprived of liberty\n* Pregnant or lactating woman, or of childbearing age without effective contraception\n* Not affiliated to a social security system\n* Inability to understand the protocol and / or to give express consent'}, 'identificationModule': {'nctId': 'NCT03926260', 'acronym': 'ELUCID', 'briefTitle': 'Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Departemental Vendee'}, 'officialTitle': 'Non-controlled Prospective Pilot Study Assessing Prognostic Performance of Circulating Tumour DNA Kinetic Analysis for Monitoring Response to Treatment of Metastatic Non-small Cell Lung Cancers', 'orgStudyIdInfo': {'id': 'CHD 160-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ctDNA analysis', 'description': 'additional blood sample of 20 ml', 'interventionNames': ['Other: ctDNA analysis']}], 'interventions': [{'name': 'ctDNA analysis', 'type': 'OTHER', 'description': 'blood sample at Baseline, 3weeks, 9 weeks after treatment, at progression if applicable', 'armGroupLabels': ['ctDNA analysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85000', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Marie MARCQ', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Jaafar BENNOUNA', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Marc DENIS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHD Vendee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Departemental Vendee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}