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Cancer Screening Test

DNA Screening Test Education for Lung Cancer Detection (FIRSTLungL301 Trial)

N/A

Recruiting

Research Sponsored by Delfi Diagnostics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

FIRSTLungL301 Trial Summary

This trial tests if offering a DNA screening test to doctors increases lung cancer screening rates in patients eligible for it.

Who is the study for?

This trial is for primary care practices with at least 50 patients eligible for lung cancer screening based on USPSTF guidelines, but who haven't been screened in the past 15 months. Practices should offer regular services and be able to handle data tasks. They shouldn't be part of other DELFI or early cancer detection studies.Check my eligibility

What is being tested?

The study tests if giving doctors access to a DNA-based lung cancer screening test (DELFI) increases the number of patients getting screened compared to doctors without it. It's about seeing if this new tool can improve how often high-risk patients get checked for lung cancer.See study design

What are the potential side effects?

Since this trial involves implementing a new diagnostic test rather than a medication or therapy, there are no direct side effects from interventions like drugs. However, any medical procedure may carry risks such as discomfort or bruising from blood draws.

FIRSTLungL301 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of practice-identified lung cancer screen-eligible individuals receiving a screening CT order and scan during the study period in each arm.

Secondary outcome measures

Estimate the number NNS with FirstLook™ to detect one additional lung cancer during the study period.

Proportion of practice-identified screen-eligible individuals receiving a CT order and scan for lung cancer screening following FirstLook™ test result during the study period.

Other outcome measures

Proportion of CTs for lung cancer screening completed within the follow-up window compared to the proportion of screening CTs ordered prior to day 0.

Proportion of SDM visits completed by the provider and subsequent confirmation of completed LDCT in the control arm versus the proportion of completed SDM visits with an ordered and completed LDCT in the intervention arm.

FIRSTLungL301 Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm BExperimental Treatment2 Interventions

Arm B (intervention) practices will receive education on FirstLook™ and have access to order FirstLook™ at the providers' discretion;

Group II: Arm A1Active Control1 Intervention

Arm A practices will be further randomized 1:1 into two groups (A1:A2) to observe lung cancer screening standard of care. Practices in A1 will be observed.

Group III: Arm A2Active Control1 Intervention

Arm A practices will be further randomized 1:1 into two groups (A1:A2) to observe lung cancer screening standard of care. Practices in A2 will receive standard education on lung cancer screening for CME credit.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Delfi Diagnostics Inc.Lead Sponsor

2 Previous Clinical Trials

17,660 Total Patients Enrolled

Lindsey Cotton, D.O.Med.Study ChairDirector, Medical Affairs

Peter Bach, MDStudy ChairChief Medical Officer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum enrolment capacity of this medical experiment?

"Affirmative. The evidence posted on clinicaltrials.gov specifies that this medicinal research, which was initially announced on October 31st 2023, is actively recruiting patients at the moment. Approximately 90 people have to be enlisted from a single location."

Answered by AI

Are seniors allowed to partake in this clinical exploration?

"This trial is seeking participants aged 18 to 99 years old. Conversely, there are 43 trials available for minors and 1,677 clinical studies open to seniors."

Answered by AI

Can I participate in this medical experiment?

"Participants aged between 18 and 99 with a confirmed diagnosis of lung cancer are eligible to participate in this trial. The clinical study is seeking 90 patients in total."

Answered by AI

Are there any available openings for participants in this investigation?

"As per the information on clinicaltrials.gov, this trial is currently enrolling suitable participants. The posting of the study was initially released on October 31st 2023 and most recently updated on November 17th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer

2023. "Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06145750.

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