Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
Study NCT ID:
NCT05306912
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2022-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of targeted (9 genes panel) methylation analysis on supernatant cfDNA to detect a malignant nodule will be evaluated.', 'timeFrame': "1st day (D0) of patients' inclusion, on morning of their ultrasound-bronchoscopy", 'description': 'Promoter methylation rates of the 9 targeted genes in the free circulating DNA of the endoscopic samples supernatant is obtained by quantitative Polymerase Chain Reaction (PCR) of bisulfite-treated DNA fragments from the cytological samples supernatant after DNA concentration and separation by size at the Centre of Cancer Research of Toulouse (CRCT).\n\nThese analyses will be performed blinded to the clinical data and the histopathology result of the lung nodule.'}], 'secondaryOutcomes': [{'measure': 'Comparison of supernatant to pathology and plasma cfDNA methylation analysis. Specificity, negative predictive value (NPV), positive predictive value (PPV) of targeted (9 genes panel) methylation analysis on supernatant cfDNA to detect a malignant nodule', 'timeFrame': "1st day (D0) of patients' inclusion, on morning of their ultrasound-bronchoscopy", 'description': "Methylation profiles of free circulating DNA from plasma obtained after centrifugation of blood samples will be obtained by the same method as described for analysis of cytopunction's supernatant methylation profile.\n\nThese analyses will be performed blinded to the clinical data and the histopathology result of the lung nodule."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Circulating free DNA', 'Methylation', 'Lung cancer', 'screening', 'lung nodule', 'radial EBUS', 'endobronchial ultrasound'], 'conditions': ['Lung Cancer', 'Lung; Node']}, 'descriptionModule': {'briefSummary': 'Lung cancer screening is based on low dose CT scan (LDCT), a highly sensitive but poorly specific tool.\n\nComplementary specific approaches are thus strongly needed, among which cell-free DNA (cfDNA) genotyping has been proven highly specific but of low sensitivity (25 to 50% for stage I diseases) due to inconstant tumor shed. Tumor biopsy is thus often required and radial endobronchial ultrasound (rEBUS) bronchoscopy is a minimally invasive approach (\\<3% complications) but of limited sensitivity in cases of nodules \\< 20 mm.\n\nThe investigators hypothesized that methylation analysis on cfDNA floating in supernatant derived from rEBUS specimens could improve rEBUS sensitivity', 'detailedDescription': "Tumor biopsy is often required to characterize indeterminate nodules. Radial endobronchial ultrasound (rEBUS) bronchoscopy is often used due to a low rate of complications but its sensitivity is limited for small nodules.\n\nThe investigators hypothesized that methylation analysis on cfDNA floating in supernatant derived from rEBUS specimens could improve rEBUS sensitivity.\n\nThe primary outcome of this pilot, diagnostic validation, monocentric study is the sensitivity of targeted (9 genes panel) methylation analysis on supernatant cfDNA to detect a malignant nodule.\n\nSecondary outcomes include the comparison of supernatant to pathology and plasma cfDNA methylation analysis.\n\nSpecificity, negative predictive value (NPV), positive predictive value (PPV) of targeted (9 genes panel) methylation analysis on supernatant cfDNA to detect a malignant nodule will be analyzed.\n\n60 patients planned for a rEBUS bronchoscopy for one, two or three \\< 20 mm nodule, without mediastinal or extra thoracic lesions (cT1N0M0) will be included.\n\nThe day of the rEBUS bronchoscopy, 2 7.5 mL blood samples are collected. rEBUS samples' supernatant, usually discarded, is saved.\n\nCell free DNA is extracted from these biological specimens at the Laboratory of Oncological Medical Biology (LBMO) in Toulouse University Cancer Institute and tested for methylation (targeted analysis on 9 genes).\n\nThe patients will be followed for one year to obtain a final diagnosis and correlate it with tissue, nodule supernatant and plasma methylation analyses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* rEBUS bronchoscopy planned for one, two or three ≤ 20 mm nodule\n* World Health Organization (WHO) Performance status 0-3\n* Informed signed consent\n* Patient affiliated or beneficiary of a social security scheme (Social Security or Universal Medical Coverage).\n\nExclusion Criteria:\n\n* Lung cancer diagnosed before the date of the procedure\n* Lung cancer strongly suspected due to mediastinal or extra thoracic lesions\n* Patient under State Medical Assistance\n* Patient deprived of liberty on administrative or judicial decision, or patient under guardianship, curators or safeguard of justice'}, 'identificationModule': {'nctId': 'NCT05306912', 'acronym': 'KOBE', 'briefTitle': 'Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules (Cancer Or Benign Endoscopy) (KOBE)', 'orgStudyIdInfo': {'id': 'RC31/20/0446'}, 'secondaryIdInfos': [{'id': 'ID-RCB 2021-A01024-37', 'type': 'OTHER', 'domain': 'ANSM'}, {'id': 'ARI 20-0446', 'type': 'OTHER_GRANT', 'domain': 'University Hospital, Toulouse'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'blood sampling', 'description': 'blood sample (2 tubes of 7.5 mL of blood = 15 mL) during the preoperative check-up on the day of the ultrasound-bronchoscopy in order to compare the sensitivity of the analysis of free circulating DNA present in the supernatant of pulmonary nodules less than 20 mm samples taken under ultrasound-bronchoscopy to that present in the plasma', 'interventionNames': ['Biological: Blood samples']}], 'interventions': [{'name': 'Blood samples', 'type': 'BIOLOGICAL', 'description': 'Patients will be taken from an additional blood sample (2 tubes of 7.5 mL of blood = 15 mL) during the preoperative check-up on the day of the ultrasound-bronchoscopy in order to compare the sensitivity of the analysis of free circulating DNA present in the supernatant of pulmonary nodules less than 20 mm samples taken under ultrasound-bronchoscopy to that present in the plasma.', 'armGroupLabels': ['blood sampling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31300', 'city': 'Toulouse', 'state': 'Occitanie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sandra BERNARD, PM', 'role': 'CONTACT', 'email': 'bernard.s@chu-toulouse.fr', 'phone': '+33561778573'}, {'name': 'Valentin HELUAIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Toulouse University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Valentin HELUAIN, MD', 'role': 'CONTACT', 'email': 'heluain.v@chu-toulouse.fr', 'phone': '+33567771439', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Valentin HELUAIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}