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DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study) | Clinical Trials | Clareo Health

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DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)

NCT04825834•Delfi Diagnostics Inc.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All Participants:
•1. Ability to understand and provide written informed consent
•2. Age ≥ 50 years
•3. Current or Former Smoker
•4. ≥ 20 pack-years (pack years = number of packs per day X number of years smoked)
•Inclusion Group 1: High Risk Patients that meet criteria 5 and 6 below:
•AND
•6. Meet one of the criteria below:
•1. No suspected or confirmed lung cancer diagnosis OR
•2. Suspected of lung cancer OR
+5 more criteria

Exclusion Criteria

•All Participants:
•1. 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)
•2. Any history of hematologic malignancies or myelodysplasia
•3. Any history of organ tissue transplantation
•4. Any history of blood product transfusion
•5. Current pregnancy
•6. Any condition that in the opinion of the Investigator should preclude the participant's participation in the study
•7. 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)
•8. Enrollment in any DELFI sponsored study

Locations (57)

Central Alabama Research

Homewood, Alabama, United States

Phoenix Medical Group

Peoria, Arizona, United States

Highlands Oncology Group - Fayetteville

Fayetteville, Arkansas, United States

Pulmonary Associates of Burlingame

Burlingame, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States

Centura Health

Colorado Springs, Colorado, United States

National Jewish Health

Denver, Colorado, United States

St. Mary's Hospital and Regional Medical

Grand Junction, Colorado, United States

Starling Physicians

New Britain, Connecticut, United States

Key Dates

Start Date

March 22, 2021

Primary Completion Date

July 15, 2025

Completion Date

July 15, 2025

Last Updated

August 8, 2025

Enrollment

2,992

ACTUAL participants

Conditions

Lung CancerHead and Neck CancerEsophageal CancerBladder CancerKidney CancerStomach CancerColorectal CancerPancreas CancerLiver CancerSkin Cancer

Interventions

Blood Sample Collection

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)

Inclusion Criteria

Exclusion Criteria

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

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Magnetic Resonance Imaging of the Lung: Oncological Applications