CompletedNot applicableNCT04825834
Official study title

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

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedBlood Sample Collection

The study team can explain what participation involves.

Who it may be forLung Cancer · Head and Neck Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 8, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?57 U.S. locations

Locations may change over time.

Who runs it?Delfi Diagnostics Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Delfi Diagnostics Inc.
Interventions being studied
Other: Blood Sample Collection
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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: 5. 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) 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) AND 6. Meet one of the criteria below: 1. No suspected or confirmed lung cancer diagnosis OR 2. Suspected of lung cancer OR 3. Confirmed, untreated lung cancer Inclusion Group 2: High Risk Patients that meet the following criteria: 7. 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. OR 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. OR 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.

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Central Alabama ResearchHomewood, Alabama
  • Phoenix Medical GroupPeoria, Arizona
  • Highlands Oncology Group - FayettevilleFayetteville, Arkansas
  • Pulmonary Associates of BurlingameBurlingame, California
  • Kaiser Permanente Los Angeles Medical CenterLos Angeles, California
  • Torrance Memorial Physician Network - Cancer CareTorrance, California
  • Centura HealthColorado Springs, Colorado
  • National Jewish HealthDenver, Colorado
  • St. Mary's Hospital and Regional MedicalGrand Junction, Colorado
  • Starling PhysiciansNew Britain, Connecticut
  • Stamford HealthStamford, Connecticut
  • BaycareClearwater, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 8, 2025. Always confirm current availability with the study team.

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