Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT05384769
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2022-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer
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': '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-01-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Screening preference', 'timeFrame': 'Upon completion of home liquid biopsy or LDCT, an average of 4 weeks.', 'description': 'The proportion of participants who agree to undergo lung cancer screening using liquid biopsy versus LDCT, with a feasibility threshold of at least 30% preferring liquid biopsy.'}], 'secondaryOutcomes': [{'measure': 'Participants who follow-through on screening 1', 'timeFrame': '6 month follow-up timepoint.', 'description': 'The proportion of participants who are screened with LDCT at 6 months in each screening group.'}, {'measure': 'Participants who follow-through on screening 2', 'timeFrame': '6 month follow-up timepoint.', 'description': 'The proportion of participants who undergo LDCT at 6 months after receiving liquid biopsy results, stratified by test result (negative vs positive).'}, {'measure': 'Participants who follow-through on screening 3', 'timeFrame': '6 month follow-up timepoint.', 'description': 'Differences in sociodemographic factors across screening preference (liquid biopsy vs. LDCT) in those who undergo screening (Exploratory).'}, {'measure': 'Participants who follow-through on screening 4', 'timeFrame': '6 month follow-up timepoint.', 'description': 'Differences in sociodemographic survey scores across screening preference (liquid biopsy vs. LDCT) in those who undergo screening (Exploratory).'}, {'measure': 'Participants who undergo low dose computed tomography of the chest (LDCT) after receiving liquid biopsy results', 'timeFrame': 'Up to 6 months', 'description': 'For those who choose liquid biopsy only. Data will be summarized using counts and percentages and tested using Chi-square analysis.'}, {'measure': 'Sociodemographic factors (age, sex, race/ethnicity, educational background)', 'timeFrame': 'At baseline visit', 'description': 'Data will be summarized using means and standard deviations or counts and percentages, depending on whether the data are continuous or categorical. Univariate tests across groups will be done using t-tests (continuous) and chi-square analysis (categorical). Non-parametric tests will be used for continuous data that are non-normally distributed data (Kruskal-Wallis) and for ordinal categorical data (Jonckheere-Terpstra). Multivariable logistic regression methods will be used to determine the primary factors predicting screening preference. Data included in the model will be determined based on clinical relevance and/or significance in univariate analysis.'}, {'measure': 'Survey scores across screening preference 1', 'timeFrame': 'At 6 month follow up', 'description': 'Survey tools will be used to understand sociodemographics, prior cancer screening, cancer worry, lung cancer risk perception, and barriers to lung cancer screening.\n\nSurvey tools utilized:Demographics tool: including sex, race/ethnicity, education level, income.'}, {'measure': 'Survey scores across screening preference 2', 'timeFrame': 'At 6 month follow up', 'description': 'Survey tools will be used to understand sociodemographics, prior cancer screening, cancer worry, lung cancer risk perception, and barriers to lung cancer screening.\n\nSurvey tools utilized: Tobacco smoking history'}, {'measure': 'Survey scores across screening preference 3', 'timeFrame': 'At 6 month follow up', 'description': 'Survey tools will be used to understand sociodemographics, prior cancer screening, cancer worry, lung cancer risk perception, and barriers to lung cancer screening.\n\nSurvey tools utilized: Prior use of colon, breast, and lung cancer screening.'}, {'measure': 'Survey scores across screening preference 4', 'timeFrame': 'At 6 month follow up', 'description': 'Survey tools will be used to understand sociodemographics, prior cancer screening, cancer worry, lung cancer risk perception, and barriers to lung cancer screening.\n\nSurvey tools utilized: Lung Cancer Screening Health Beliefs Survey (lung cancer risk perception and barriers to lung cancer screening).'}, {'measure': 'Survey scores across screening preference 5', 'timeFrame': 'At 6 month follow up', 'description': 'Survey tools will be used to understand sociodemographics, prior cancer screening, cancer worry, lung cancer risk perception, and barriers to lung cancer screening.\n\nSurvey tools utilized: Cancer Worry Scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Carcinoma']}, 'descriptionModule': {'briefSummary': "This clinical trial investigates how practical and doable (feasibility) cell-free deoxyribonucleic acid (DNA) liquid biopsy is in screening high-risk patients for lung cancer. Currently, a low dose computed tomography (CT) scan is used to screen for lung cancer, however, due to various factors, few high-risk patients are screened. Liquid biopsy utilizes technology that can detect small amounts of DNA shed by cancer cells and may be able to spot lung cancer at an earlier stage. If a positive result comes back from the liquid biopsy, a patient may be more willing to get a low dose CT (LDCT) scan, possibly confirming the biopsy's findings and thus leading to more early lung cancer detection.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine the feasibility of lung cancer screening using liquid biopsy in a community setting.\n\nSECONDARY OBJECTIVES:\n\nI. To determine screening follow-through rates in those who agreed to undergo screening by preferred modality (liquid biopsy versus \\[vs\\] LDCT).\n\nII. To determine the rate of LDCT following liquid biopsy (in those who underwent liquid biopsy) after stratifying by test result (negative versus positive).\n\nIII. To compare participant sociodemographic factors (age, sex, race/ethnicity, educational background) and survey scores across screening preference (liquid biopsy vs. LDCT).\n\nOUTLINE: Participants choose 1 of 2 cohorts.\n\nCOHORT A: Participants undergo collection of blood sample (liquid biopsy), with option to undergo LDCT if liquid biopsy results are positive.\n\nCOHORT B: Participants undergo low dose CT with optional liquid biopsy on the same day as LDCT.\n\nAfter completion of study, patients are followed up at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented written informed consent of the participant.\n* Age 50-80 years.\n* Smoking history of \\>= 20 pack-years and if quit, quit within 15 years.\n* Received referral for counseling for lung cancer screening and would qualify for LDCT.\n* Health Insurance that will pay for a LDCT for lung cancer screening at either City of Hope Duarte, Newport Beach (Newport Diagnostic Imaging), or Lancaster (Renaissance Imaging/Antelope Valley Outpatient Imaging Center).\n* Willingness to provide blood sample.\n* English speaking.\n* Consent to undergo lung cancer screening with either liquid biopsy (LB) or LDCT.\n\nExclusion Criteria:\n\n* Symptoms of lung cancer.\n* Chest CT scan or chest positron emission tomography (PET)/CT within 12 months.\n* Any cancer diagnosis within past 5 years, excluding non-melanoma skin cancer.\n* Unable to undergo LDCT at either City of Hope Duarte, Newport Beach, or Lancaster.'}, 'identificationModule': {'nctId': 'NCT05384769', 'briefTitle': 'Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Feasibility Study of Lung Cancer Screening Using Cell-Free DNA Liquid Biopsy at Home in High-Risk Current and Former Smokers', 'orgStudyIdInfo': {'id': '21591'}, 'secondaryIdInfos': [{'id': 'NCI-2022-02513', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '21591', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}, {'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A (liquid biopsy, optional LDCT)', 'description': 'Participants undergo collection of blood sample (liquid biopsy), with option to undergo LDCT if liquid biopsy results are positive.', 'interventionNames': ['Procedure: Liquid Biopsy', 'Procedure: Low Dose Computed Tomography of the Chest', 'Other: Survey Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B (LDCT, optional liquid biopsy)', 'description': 'Participants undergo low dose CT with optional liquid biopsy on the same day as LDCT.', 'interventionNames': ['Procedure: Liquid Biopsy', 'Procedure: Low Dose Computed Tomography of the Chest', 'Other: Survey Administration']}], 'interventions': [{'name': 'Liquid Biopsy', 'type': 'PROCEDURE', 'otherNames': ['Plasma Biopsy'], 'description': 'Undergo liquid biopsy', 'armGroupLabels': ['Cohort A (liquid biopsy, optional LDCT)', 'Cohort B (LDCT, optional liquid biopsy)']}, {'name': 'Low Dose Computed Tomography of the Chest', 'type': 'PROCEDURE', 'otherNames': ['LDCT', 'Low Dose Chest Computed Tomography', 'Low-dose Chest Computed Tomography', 'Low-dose Chest CT'], 'description': 'Undergo low dose CT', 'armGroupLabels': ['Cohort A (liquid biopsy, optional LDCT)', 'Cohort B (LDCT, optional liquid biopsy)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Cohort A (liquid biopsy, optional LDCT)', 'Cohort B (LDCT, optional liquid biopsy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dan Raz', 'role': 'CONTACT', 'email': 'draz@coh.org', 'phone': '626-256-4673'}, {'name': 'Dan Raz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'centralContacts': [{'name': 'Dan Raz, MD', 'role': 'CONTACT', 'email': 'draz@coh.org', 'phone': '626-359-8111'}], 'overallOfficials': [{'name': 'Dan Raz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}