COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine whether availability of DNA Evaluation of Fragments for Early Interception (DELFI) Lung Cancer Screening Test, FirstLook™ to practicing physicians affects overall lung cancer screening rates among their patients who are recommended and eligible for screening based on 2021 United States Preventive Services Task Force (USPSTF) but are not up to date with it. DELFI hypothesized that patients in the care of physicians or practice groups who have FirstLook™ will have increased lung screening rates compared to patients in the care of physicians or practice groups who do not have access to FirstLook™.

Official Title

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

Quick Facts

Study Start:2023-10-31
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06145750

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Practice offers primary care services. Primary care services may include, but are not limited to: community health centers, academic outpatient facilities, private practices of family or general internal medicine, and Veterans Administration outpatient primary care clinics.
  2. 2. Practice has a lung cancer screening population of a minimum of 50 individuals upon first review of patient records. a. Lung cancer screening eligible population is defined as meeting the 2021 USPSTF guideline recommendations (current and former smokers 50-80 years of age, 20 pack year or more smoking history, have not quit more than 15 years ago) b. Individuals have had a clinic visit in the past 12 months, and c. Individuals have not had a CT for lung cancer screening in the last 15 months.
  3. 3. Practice can complete EMR data extraction and EDC entry during the study.
  4. 4. Practice scores a 4 (agree) or 5 (strongly agree) on a 5-point Likert scale for physical and payer benefit access to LDCT.
  5. 5. The practice utilizes conveniently located phlebotomy that accepts same-day services.
  1. 1. Practice is currently participating in other DELFI studies.
  2. 2. Practice is actively participating in any other cancer screening blood-based biomarker studies which includes return of results.

Contacts and Locations

Principal Investigator

Peter Bach, MD
STUDY_CHAIR
Chief Medical Officer

Study Locations (Sites)

DARTNet Institute
Aurora, Colorado, 80045
United States
University Of Florida
Jacksonville, Florida, 32209
United States
Duke University
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Delfi Diagnostics Inc.

  • Peter Bach, MD, STUDY_CHAIR, Chief Medical Officer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-31
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-10-31
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • Lung Cancer Screening
  • Early Diagnosis
  • Low Dose CT Scan
  • CT Scan
  • Lung Neoplasms
  • Respiratory Tract Neoplasms
  • Thoracic Neoplasms
  • Lung Diseases
  • Respiratory Tract Diseases
  • Biomarkers
  • Lung Cancer Prevention
  • Fragmentomics
  • CAT Scan
  • Early Detection
  • NSCLC
  • Adenocarcinoma
  • Lung Malignancy
  • Liquid Biopsy
  • LDCT

Additional Relevant MeSH Terms

  • Lung Cancer