300 Participants NeededMy employer runs this trial

Lung Cancer Screening for Lung Cancer

(CHAMP Trial)

Recruiting at 2 trial locations
LS
Overseen ByLaura Seegmiller
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Jill Kolesar
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to make lung cancer screening easier and more accessible. It tests the DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test alongside the traditional low-dose CT scan. The goal is to determine if the blood test can simplify the process and increase screening rates. Individuals who have smoked for 20 years or more and either still smoke or quit within the last 15 years might be suitable candidates. Participants can choose between the blood test, a CT scan, or opt out of screening, with follow-up options discussed annually. As an unphased trial, this study offers participants the chance to contribute to innovative research that could transform lung cancer screening for future patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found the DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test to be safe and easy to handle. This test involves a simple blood draw to check for DNA changes that might indicate lung cancer. Research has shown that this blood test effectively detects early-stage lung cancer with high accuracy. So far, studies have reported no major side effects or safety issues.

The low-dose CT scan is already a standard method for lung cancer screening and is recommended by the U.S. Preventive Services Task Force. It is generally safe, although some people may worry about radiation exposure. However, the radiation dose is very low, and the benefits of early cancer detection usually outweigh the risks.

Overall, both the blood test and the low-dose CT scan are considered safe options for lung cancer screening, with the blood test being a less invasive choice.12345

Why are researchers excited about this trial?

Researchers are excited about the DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test because it offers a new, minimally invasive way to detect lung cancer early. Unlike the standard low-dose CT scans that require imaging technology, this blood test analyzes patterns in cell-free DNA fragments using advanced whole-genome sequencing and machine-learning techniques. This method could make lung cancer screening more accessible and less intimidating, as it only requires a simple blood draw. Plus, it complements existing CT scans by helping to identify candidates who might need further imaging, potentially catching cancer sooner.

What evidence suggests that this trial's treatments could be effective for lung cancer screening?

Studies have shown that the DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test effectively detects lung cancer early. It has an 80% sensitivity, correctly identifying 80% of individuals with lung cancer. Additionally, it boasts a 99.8% negative predictive value, accurately confirming the absence of lung cancer when the test result is negative. This reliability makes it a strong option for early detection. Participants in this trial may opt for the DELFI blood test, which analyzes tiny DNA fragments in the blood using advanced computer techniques to detect cancer signs. This blood test offers a less invasive alternative to traditional screening methods.34567

Who Is on the Research Team?

JK

Jill Kolesar, PharmD, MS, FCCP

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults aged 50-77 who have smoked the equivalent of a pack a day for at least 20 years and currently smoke or quit within the last 15 years. Participants must be able to give consent and not have had lung cancer screening in the past year.

Inclusion Criteria

I am between 50 and 77 years old.
Smoking pack-year history of ≥ 20 years
Current smoker or quit smoking 15 or less years ago
See 1 more

Exclusion Criteria

Self-report of lung cancer screening in the last 12 months
Psychiatric illness/social situations that would limit compliance with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Consent and Decision-Making

Participants engage in shared decision-making with a pharmacist about lung cancer screening options

1-2 weeks
1 visit (in-person)

Initial Screening

Participants undergo either the DELFI blood test or a low-dose CT scan for lung cancer screening

6 months
1 visit (in-person) for blood test or CT scan

Follow-up

Participants with a positive blood test undergo confirmatory CT imaging; all participants are monitored for safety and effectiveness

12 months
Annual follow-up visits

Annual Re-screening

Participants with a negative blood test are re-screened annually for an additional year

12 months
1 visit (in-person) annually

What Are the Treatments Tested in This Trial?

Interventions

  • DELFI Diagnostics FirstLook Lung Cancer Screening Blood Test
  • Low-Dose CT Scan

Trial Overview

The study compares two ways to screen for lung cancer: a low-dose CT scan and a new blood test (DELFI Diagnostics FirstLook). Screening is offered through community pharmacists, with follow-up based on results.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: DELFI FirstLook Lung Cancer Screening Blood TestExperimental Treatment1 Intervention
Group II: Low-Dose CTActive Control1 Intervention
Group III: No lung cancer screeningActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jill Kolesar

Lead Sponsor

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

An effective and affordable blood test for lung cancer early ...

LungCanSeek, an artificial intelligence (AI)-integrated 4-protein blood test, demonstrated promising performance for lung cancer early detection ...

Health Systems - DELFI

What is the test performance? FirstLook Lung has 99.8% negative predictive value (NPV) and is clinically validated for lung cancer screening in USPSTF-eligible ...

DELFI Diagnostics' Blood Test Validated for Early Lung ...

The FirstLook Lung test achieved 80% sensitivity and a 99.8% negative predictive value, indicating its effectiveness in accurately identifying ...

Implementation of a Blood-Based Screening Test to ...

To optimize lung cancer screening impact at the healthcare system level, we implemented DELFI FirstLook™ Lung. (FLL)*(6) blood-based screening as an adjunct ...

CHAMP Lung Cancer Screening Program

Participants may choose to receive the DELFI Diagnostics FirstLook Lung test, a blood-based screening test designed to support early detection ...

Innovations in Early Lung Cancer Detection - PMC - NIH

DELFI-L101 was completed in 2023 and enrolled individuals at an elevated risk of developing lung cancer per the 2021 USPSTF guideline ...

Cell-Free DNA Assay Achieves High Negative Predicative ...

An 80% sensitivity for lung cancer was observed with the liquid biopsy, with high sensitivity observed for early-stage disease, as well.