Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-25 @ 12:08 AM
Study NCT ID:
NCT05462795
Status:
COMPLETED
Last Update Posted:
2024-12-16
First Post:
2022-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liquid Biopsy for Early Non-small Lung Cancer Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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': 'D000073890', 'term': 'Liquid Biopsy'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2022-07-13', 'studyFirstSubmitQcDate': '2022-07-13', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Indeterminate pulmonary nodule study cohort: Sensitivity and specificity of liquid biopsy test for malignancy', 'timeFrame': '9 months', 'description': 'The patients with indeterminate nodules will be used to separately estimate the sensitivity (in those with lung cancer) and specificity (in those without lung cancer). At least 35 patients with lung cancer will provide an estimate of the standard error of the sensitivity \\< 0.09. Specificity will also be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals.'}, {'measure': 'Known lung cancer for surgical resection study cohort', 'timeFrame': '9 months', 'description': 'To determine the correlation between the longitudinal marker levels and time to progression, to allow adjustment for relevant clinical characteristics.\n\nCorrelations between change in the methylation results and response to therapy using radiographic findings (response, stable disease, progression) at 6 months post-baseline time point will be analyzed using a multinomial regression model.'}, {'measure': 'Healthy volunteers study cohort', 'timeFrame': '9 months', 'description': 'Specificity will be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals.'}, {'measure': 'Benign lung disease cohort', 'timeFrame': '9 months', 'description': 'Thirty-five patients with benign lung disease will provide an estimate of the standard error of the specificity \\<0.09. Assuming a specificity value of 0.91 (32 negative/35 total), the exact 95% confidence interval is (0.77, 0.98). The specificity will be estimated separately, with an exact 95% confidence interval, for each of the benign lung disease subtypes as an exploratory analysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung cancer', 'Biomarker', 'DNA methylation'], 'conditions': ['Non Small-cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This clinical trial will assess the performance of a liquid biopsy assay to identify cancer in indeterminant pulmonary nodules identified by CT screening of high-risk individuals and evaluate the capability of the liquid biopsy assay to monitor response to surgical resection.', 'detailedDescription': 'This clinical study examines the feasibility of a liquid biopsy methylation assay to detect non-small lung cancer. First, the investigators will apply their liquid biopsy assay to screen for lung cancer in indeterminate pulmonary nodules suspicious for cancer. Second, the investigators will assess the utility of liquid biopsy to assess tumor dynamics after surgical resection with curative intent. Third, the investigators will assess the presence or absence of this methylation assay in healthy normal persons without a history of lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients and volunteers will be recruited from the BUMC-T Pulmonary and UACC clinics (Indeterminate pulmonary nodule); through study posting on ClinicalTrials.gov and word of mouth (Healthy volunteers); UACC Thoracic Surgery Clinic (Pre-post lung cancer surgery); and Pulmonary Clinic (Benign Lung Disease).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Indeterminate pulmonary nodule study cohort\n\n* Inclusion criteria: Patients undergoing a biopsy of an indeterminate lung nodule by surgical excision, bronchoscopic biopsy or Interventional Radiology directed biopsy\n* Exclusion criteria: No known concurrent cancer\n\nKnown lung cancer for surgical resection study cohort\n\n* Inclusion criteria: Patients with known non-small cell lung cancer who will have surgical resection for treatment\n* Exclusion criteria: N/A\n\nHealthy volunteer cohort\n\n* Inclusion criteria: Healthy persons\n* Exclusion criteria: No known current cancer or history of cancer within 5 years\n\nBenign lung disease cohort\n\n* Inclusion criteria: Patients with the following categories of benign lung disease: COPD/emphysema, Granulomatous infection, Interstitial lung disease including pulmonary fibrosis and interstitial lung disease.\n* Exclusion criteria: N/A'}, 'identificationModule': {'nctId': 'NCT05462795', 'briefTitle': 'Liquid Biopsy for Early Non-small Lung Cancer Detection', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Liquid Biopsy to Distinguish Malignant From Benign Pulmonary Nodules and to Monitor Response to Therapy', 'orgStudyIdInfo': {'id': '2107020697'}, 'secondaryIdInfos': [{'id': 'R43CA257133-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R43CA257133-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Indeterminate pulmonary nodule study cohort', 'description': 'Patients undergoing a biopsy of an indeterminate lung nodule by surgical excision, bronchoscopic biopsy or Interventional Radiology directed biopsy', 'interventionNames': ['Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule']}, {'label': 'Known lung cancer for surgical resection study cohort', 'description': 'Patients with known non-small cell lung cancer who will have surgical resection for treatment', 'interventionNames': ['Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection']}, {'label': 'Healthy volunteer cohort', 'description': 'Healthy volunteers with a) no current diagnosis of cancer; b) no history of cancer over the last 5 years; and c) no existing known benign lung disease that is currently requiring treatment with medication.', 'interventionNames': ['Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer']}, {'label': 'Benign lung disease cohort', 'description': 'Patients with the following categories of benign lung disease:\n\n* COPD/emphysema\n* Granulomatous infection\n* Interstitial lung disease including pulmonary fibrosis and interstitial lung disease.', 'interventionNames': ['Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease']}], 'interventions': [{'name': 'Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule', 'type': 'DIAGNOSTIC_TEST', 'description': '10 cc of blood is collected at one time point, which is prior to biopsy procedure', 'armGroupLabels': ['Indeterminate pulmonary nodule study cohort']}, {'name': 'Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection', 'type': 'DIAGNOSTIC_TEST', 'description': '10 cc of blood is collected at three time points: 1) before surgery; 2) 4-6 weeks post surgery; and 3) 6 months post surgery', 'armGroupLabels': ['Known lung cancer for surgical resection study cohort']}, {'name': 'Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer', 'type': 'DIAGNOSTIC_TEST', 'description': '10 cc of blood is collected at one time point', 'armGroupLabels': ['Healthy volunteer cohort']}, {'name': 'Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease', 'type': 'DIAGNOSTIC_TEST', 'description': '30 cc of blood is collected at one time point', 'armGroupLabels': ['Benign lung disease cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Linda Garland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}