Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-26 @ 1:29 AM
Study NCT ID:
NCT06074133
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2023-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-18', 'size': 583065, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-19T12:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2023-10-05', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients with benign disease who underwent invasive diagnostic procedures.', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'The time to diagnosis (in days) for patients with cancer.', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Measure time needed to provide the CBM Value to clinician', 'timeFrame': 'Up to approximately 2 years', 'description': 'Number of days'}, {'measure': 'Measure time needed to obtain hs CYFRA 21-1 values', 'timeFrame': 'Up to approximately 2 years', 'description': 'Number of hours (days)'}, {'measure': 'Measure time needed to perform radiomics', 'timeFrame': 'Up to approximately 2 years', 'description': 'Number of hours (days)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Nodule']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter observational study aim at estimating the potential clinical utility of the CBM and at establishing the SOPs and protocols for a future randomized control trial.', 'detailedDescription': 'Objectives:\n\n* To obtain the combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score in a prospective observational trial and estimate potential clinical utility compared to the Mayo Model.\n* To establish standard operating procedures (SOPs) and protocols in a prospective observational trial in anticipation of a future randomized control trial. These include the REDCAP data input protocols, the radiomic protocols, blood draws in the CLIA environment, and estimating the CBM score in a time reasonable for clinical practice (\\< 2 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients recruited from pulmonary or thoracic clinics that have indeterminate pulmonary nodules', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\> 21 y/o\n* IPNs 8-30mm referred for evaluation Figure 4. AUC and reclassification of Combined Biomarker Model\n* Intermediate risk IPN defined as 10-70% risk after applying Mayo risk predictor model\n* Solid nodules or part-solid nodules with solid component \\>=8mm\n* CT scan with nodule of concern performed within 60 days of enrollment\n\nExclusion Criteria:\n\nPure ground glass nodule or subsolid nodule with solid component \\<8mm\n\n* Currently on therapy for any cancer\n* History of primary lung cancer within the last 5 years\n* Multiple nodules highly suspicious for metastatic disease\n* Other malignancy within the last 2 year - Excluding skin cancer other than melanoma\n* Pregnant women\n* Prisoners\n* Inability to provide informed consent\n* Serologic evidence of active fungal infection'}, 'identificationModule': {'nctId': 'NCT06074133', 'briefTitle': 'A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules A Multicenter Prospective Observational Pilot Study', 'orgStudyIdInfo': {'id': 'VICC-EDTHO23230'}, 'secondaryIdInfos': [{'id': 'NCI-2023-05725', 'type': 'REGISTRY', 'domain': 'NCI, Clinical Trials Reporting Program'}, {'id': '5R01CA252964-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01CA252964-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Indeterminate Pulmonary Nodules', 'description': 'A combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score will be obtained to estimate potential clinical utility compared to the Mayo Model.', 'interventionNames': ['Procedure: Blood collection', 'Procedure: Chest Computed Tomography']}], 'interventions': [{'name': 'Blood collection', 'type': 'PROCEDURE', 'description': 'Undergo blood draw', 'armGroupLabels': ['Indeterminate Pulmonary Nodules']}, {'name': 'Chest Computed Tomography', 'type': 'PROCEDURE', 'description': 'Undergo standard of care chest Computed Tomography', 'armGroupLabels': ['Indeterminate Pulmonary Nodules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanderbilt-Ingram Services for Timely Access', 'role': 'CONTACT', 'email': 'cip@vumc.org', 'phone': '800-811-8480'}, {'name': 'Melissa New, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rocky Mountain Regional VA Medical Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanderbilt-Ingram Services for Timely Access', 'role': 'CONTACT', 'email': 'cip@vumc.org', 'phone': '800-811-8480'}, {'name': 'Alex Kaizer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanderbilt-Ingram Service Services for Timely Access', 'role': 'CONTACT', 'email': 'cip@vumc.org', 'phone': '800-811-8480'}, {'name': 'Eric Grogan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University/Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanderbilt-Ingram Services for Timely Access', 'role': 'CONTACT', 'email': 'cip@vumc.org', 'phone': '800-811-8480'}, {'name': 'Eric Grogan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VA Tennessee Valley Healthcare Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Vanderbilt-Ingram Services for Timely Access', 'role': 'CONTACT', 'email': 'cip@vumc.org', 'phone': '800-811-8480'}], 'overallOfficials': [{'name': 'Eric Grogan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University/Ingram Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Thoracic Surgery & Medicine', 'investigatorFullName': 'Eric Grogan', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}