Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT04825834
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2021-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D012878', 'term': 'Skin 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'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Residual blood specimens may be used to develop and evaluate performance of biomarker assays to detect cancers or other conditions, laboratory process improvements, and proficiency testing. Residual blood specimens will be de-identified and will be stored for no more than 20 years.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2992}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-03-30', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of lung cancer detection measured by sensitivity, specificity, and the AUC of the ROC.', 'timeFrame': 'Approximately 12 months'}], 'secondaryOutcomes': [{'measure': 'Accuracy (sensitivity and specificity) in clinical subgroups of interest', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Prevalence-based measures, including positive predictive value (PPV), negative predictive value (NPV), and number needed to screen (NNS)', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Accuracy of tumor of origin (confusion matrix of predicted versus actual cancer type)', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Adverse events (AEs) associated with the blood specimen collection', 'timeFrame': 'Point in time of blood specimen collection (1day) at enrollment'}, {'measure': 'Expected distribution of the DELFI score in the intended use population and clinical subgroups of interest', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Association of genomic features with clinical subgroups of interest', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Analytical performance (e.g. repeatability/reproducibility)', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Accuracy of multi-cancer detection measured by sensitivity, specificity, and the AUC of the ROC and tissue of origin (TOO) accuracy', 'timeFrame': 'Approximately 12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Head and Neck Cancer', 'Esophageal Cancer', 'Bladder Cancer', 'Kidney Cancer', 'Stomach Cancer', 'Colorectal Cancer', 'Pancreas Cancer', 'Liver Cancer', 'Skin Cancer']}, 'referencesModule': {'references': [{'pmid': '38829053', 'type': 'BACKGROUND', 'citation': 'Mazzone PJ, Bach PB, Carey J, Schonewolf CA, Bognar K, Ahluwalia MS, Cruz-Correa M, Gierada D, Kotagiri S, Lloyd K, Maldonado F, Ortendahl JD, Sequist LV, Silvestri GA, Tanner N, Thompson JC, Vachani A, Wong KK, Zaidi AH, Catallini J, Gershman A, Lumbard K, Millberg LK, Nawrocki J, Portwood C, Rangnekar A, Sheridan CC, Trivedi N, Wu T, Zong Y, Cotton L, Ryan A, Cisar C, Leal A, Dracopoli N, Scharpf RB, Velculescu VE, Pike LRG. Clinical Validation of a Cell-Free DNA Fragmentome Assay for Augmentation of Lung Cancer Early Detection. Cancer Discov. 2024 Nov 1;14(11):2224-2242. doi: 10.1158/2159-8290.CD-24-0519.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study, DELFI-L101, is to train and test classifiers for lung cancer detection using the DELFI assay and other biomarker and clinical features.', 'detailedDescription': 'Subjects will be enrolled into the DELFI-L101 study after informed consent and eligibility is confirmed. At enrollment, subjects will have blood specimens collected (\\~40 mL) and 12 months post-enrollment their medical records will be reviewed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals ≥ 50 years of age who are eligible for lung cancer screening from medical, surgical, sub- specialty clinics, lung cancer screening, lung nodule, thoracic surgery, and chest clinic practices.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll Participants:\n\n1. Ability to understand and provide written informed consent\n2. Age ≥ 50 years\n3. Current or Former Smoker\n4. ≥ 20 pack-years (pack years = number of packs per day X number of years smoked)\n\n Inclusion Group 1: High Risk Patients that meet criteria 5 and 6 below:\n5. Prior thoracic imaging with computed tomography (CT) within 12 months of enrollment (CT imaging for lung cancer screening for participants meeting inclusion criteria 6a and 6b; or CT imaging for lung cancer screening or diagnostic CT for participants meeting inclusion criteria 6c)\n\n OR Planned thoracic imaging (CT) as part of standard of care within 6 weeks of enrollment (CT imaging for lung cancer screening for participants meeting inclusion criteria 6a and 6b; or CT imaging for lung cancer screening or diagnostic CT for participants meeting inclusion criteria 6c)\n\n AND\n6. Meet one of the criteria below:\n\n 1. No suspected or confirmed lung cancer diagnosis OR\n 2. Suspected of lung cancer OR\n 3. Confirmed, untreated lung cancer\n\n Inclusion Group 2: High Risk Patients that meet the following criteria:\n7. Pathologic confirmed, invasive non-lung cancer diagnosis, originating from the esophagus (upper), colon or rectum, pancreas, stomach (including lower esophagus), head and neck, skin (excluding cutaneous basal cell and squamous cell carcinoma) kidney, or liver, with no prior systemic therapy, definitive therapy, radiation, or surgical resection.\n\nOR Clinically confirmed invasive non-lung cancer diagnosis originating from the pancreas, kidney, or liver, based on imaging and clinical judgment with planned treatment and no prior systemic therapy, definitive therapy, radiation, or surgical resection.\n\nOR Clinically (based on imaging and clinical judgment) or pathologically confirmed non-invasive or invasive bladder cancer with planned treatment and no prior systemic therapy, definitive therapy, radiation or surgical resection.\n\nExclusion Criteria:\n\nAll Participants:\n\n1. Prior systemic therapy, definitive therapy, radiation, or surgical resection for cancer within one year prior to enrollment (with the exception of organ biopsies or surgery for non-melanoma skin cancer)\n2. Any history of hematologic malignancies or myelodysplasia\n3. Any history of organ tissue transplantation\n4. Any history of blood product transfusion\n5. Current pregnancy\n6. Any condition that in the opinion of the Investigator should preclude the participant's participation in the study\n7. Prior systemic therapy, definitive therapy, radiation, or surgical resection for the enrollment cancer diagnosis (with the exception of organ biopsies or surgery for non-melanoma skin cancer are not exclusionary)\n8. Enrollment in any DELFI sponsored study"}, 'identificationModule': {'nctId': 'NCT04825834', 'acronym': 'DELFI-L101', 'briefTitle': 'DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Delfi Diagnostics Inc.'}, 'officialTitle': 'DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)', 'orgStudyIdInfo': {'id': 'DELFI-L101 Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals eligible for Lung Cancer screening with Lung Cancer diagnosis', 'interventionNames': ['Other: Blood Sample Collection']}, {'label': 'Individuals eligible for Lung Cancer screening with no cancer diagnosis', 'interventionNames': ['Other: Blood Sample Collection']}, {'label': 'Individuals eligible for Lung Cancer screening with Non-Lung Cancer diagnosis', 'interventionNames': ['Other: Blood Sample Collection']}], 'interventions': [{'name': 'Blood Sample Collection', 'type': 'OTHER', 'description': 'Subjects enrolled in the DELFI-L101 will have blood specimens collected (\\~40 mL) at enrollment.', 'armGroupLabels': ['Individuals eligible for Lung Cancer screening with Lung Cancer diagnosis', 'Individuals eligible for Lung Cancer screening with Non-Lung Cancer diagnosis', 'Individuals eligible for Lung Cancer screening with no cancer diagnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'Central Alabama Research', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Medical Group', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group - Fayetteville', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '94010', 'city': 'Burlingame', 'state': 'California', 'country': 'United States', 'facility': 'Pulmonary Associates of Burlingame', 'geoPoint': {'lat': 37.5841, 'lon': -122.36608}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Memorial Physician Network - Cancer Care', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Centura Health', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': "St. Mary's Hospital and Regional Medical", 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '06051', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Starling Physicians', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '06904', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Stamford Health', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Baycare', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33065', 'city': 'Coral Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Oncology & Hematology Associates of West Broward', 'geoPoint': {'lat': 26.27119, 'lon': -80.2706}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital Cancer Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Cancer Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Charter Research - 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