Lung Cancer Screening for Lung Cancer
(CHAMP Trial)
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Consent and Decision-Making
Participants engage in shared decision-making with a pharmacist about lung cancer screening options
Initial Screening
Participants undergo either the DELFI blood test or a low-dose CT scan for lung cancer screening
Follow-up
Participants with a positive blood test undergo confirmatory CT imaging; all participants are monitored for safety and effectiveness
Annual Re-screening
Participants with a negative blood test are re-screened annually for an additional year
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
Participants may choose to receive the DELFI Diagnostics FirstLook Lung test, a blood-based screening test designed to support early detection of lung cancer. The test analyzes patterns in cell-free DNA fragments using whole-genome sequencing and machine-learning techniques. Designed to augment traditional low-dose CT screening, it offers a minimally invasive and accessible option for early lung cancer detection. If a participant elects to receive this test, a blood sample will be collected at a study clinic and sent to a DELFI Diagnostics lab without any personal identifying health information attached. After processing, results are returned to the study team. Participants will be notified if results are not elevated, in which case repeating the test in one year is recommended. If results are elevated, study staff will recommend follow-up screening with a low-dose CT scan from local clinic for further evaluation. Both the blood test and CT will be provided by the study at no cost.
Participants can choose to follow current US Preventive Services Task Force recommendations of a low-dose CT scan ordered through their primary care physician.
Participants chose to not participate in lung cancer screening. Annually, participants will be informed about lung cancer screening options and given the opportunity to participate in one of the screening options. Participants will have the ability to change their mind and choose one of the lung cancer screening options in between their annual screening discussion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jill Kolesar
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
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 ...
4.
delfidiagnostics.com
delfidiagnostics.com/wp-content/uploads/2025/10/DELFI-and-AHN-Rescue-Lung-Conf-2025.pdfImplementation 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 ...
7.
cancernetwork.com
cancernetwork.com/view/cell-free-dna-assay-achieves-high-negative-predicative-value-in-lung-cancerCell-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.
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