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

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Conditions

Lung CancerHead and Neck CancerEsophageal CancerBladder CancerKidney CancerStomach CancerColorectal CancerPancreas CancerLiver CancerSkin Cancer

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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 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.

Official Title

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

Quick Facts

Study Start:2021-03-22
Study Completion:2025-07-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04825834

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:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ability to understand and provide written informed consent
  2. 2. Age ≥ 50 years
  3. 3. Current or Former Smoker
  4. 4. ≥ 20 pack-years (pack years = number of packs per day X number of years smoked)
  5. 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)
  6. 6. Meet one of the criteria below:
  7. 1. No suspected or confirmed lung cancer diagnosis OR
  8. 2. Suspected of lung cancer OR
  9. 3. Confirmed, untreated lung cancer
  10. 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.
  1. 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. 2. Any history of hematologic malignancies or myelodysplasia
  3. 3. Any history of organ tissue transplantation
  4. 4. Any history of blood product transfusion
  5. 5. Current pregnancy
  6. 6. Any condition that in the opinion of the Investigator should preclude the participant's participation in the study
  7. 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. 8. Enrollment in any DELFI sponsored study

Contacts and Locations

Principal Investigator

Peter Mazzone, MD, MPH
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Luke RG Pike, MD, DPhil
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Central Alabama Research
Homewood, Alabama, 35209
United States
Phoenix Medical Group
Peoria, Arizona, 85381
United States
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, 72703
United States
Pulmonary Associates of Burlingame
Burlingame, California, 94010
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505
United States
Centura Health
Colorado Springs, Colorado, 80907
United States
National Jewish Health
Denver, Colorado, 80206
United States
St. Mary's Hospital and Regional Medical
Grand Junction, Colorado, 81501
United States
Starling Physicians
New Britain, Connecticut, 06051
United States
Stamford Health
Stamford, Connecticut, 06904
United States
Baycare
Clearwater, Florida, 33756
United States
Oncology & Hematology Associates of West Broward
Coral Springs, Florida, 33065
United States
Holy Cross Hospital Cancer Center
Fort Lauderdale, Florida, 33308
United States
Miami Cancer Institute
Miami, Florida, 33176
United States
Charter Research - The Villages
Orlando, Florida, 32803
United States
Millennium Physicians Group, LLC
Port Charlotte, Florida, 33952
United States
Charter Research - The Villages
The Villages, Florida, 32162
United States
Pulmonary and Sleep Specialists of Northeast Georgia - Dacula
Dacula, Georgia, 30019
United States
Christie Clinic
Champaign, Illinois, 61822
United States
Duly Health and Care
Joliet, Illinois, 60435
United States
Edward-Elmhurst Healthcare
Naperville, Illinois, 60540
United States
The Iowa Clinic
West Des Moines, Iowa, 50266
United States
Hutchinson Clinic
Hutchinson, Kansas, 67502
United States
Louisville Pulmonary Care, PLLC
Louisville, Kentucky, 40207
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Memorial Gulfport
Gulfport, Mississippi, 39051
United States
Washington University at St. Louis
Saint Louis, Missouri, 63110
United States
Missouri Baptist Medical Center
Saint Louis, Missouri, 63131
United States
Holy Name Pulmonary Associates
Englewood, New Jersey, 07631
United States
Atlantic Digestive Health Institute
Morristown, New Jersey, 07960
United States
Oncology Hematology Specialists
Mountain Lakes, New Jersey, 07046
United States
MedCorps Asthma and Pulmonary Specialists - Sewell
Sewell, New Jersey, 08080
United States
CHEAR Center LLC
Bronx, New York, 10455
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Northwell Health
New York, New York, 10075
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
East Carolina University
Greenville, North Carolina, 27834
United States
Piedmont Healthcare
Statesville, North Carolina, 28625
United States
Wilmington Health
Wilmington, North Carolina, 28401
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
United States
Respiratory Specialists, Ltd.
Wyomissing, Pennsylvania, 19610
United States
Cancer Care Associates of York
York, Pennsylvania, 17403
United States
Ralph H. Johnson Veterans Affairs Medical Center
Charleston, South Carolina, 29401
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Baptist Cancer Center
Memphis, Tennessee, 38120
United States
Austin Regional Clinic ARC Clinical Research at Wilson Parke
Austin, Texas, 78726
United States
Premier Family Physicians
Austin, Texas, 78735
United States
Pulmonary Critical Care & Sleep Associates, P.A.
Conroe, Texas, 77304
United States
Huntsville Research Institute, LLC
Huntsville, Texas, 77340
United States
ProHealth Care
Waukesha, Wisconsin, 53188
United States

Collaborators and Investigators

Sponsor: Delfi Diagnostics Inc.

  • Peter Mazzone, MD, MPH, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic
  • Luke RG Pike, MD, DPhil, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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 Date2021-03-22
Study Completion Date2025-07-15

Study Record Updates

Study Start Date2021-03-22
Study Completion Date2025-07-15

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Cancer
  • Head and Neck Cancer
  • Esophageal Cancer
  • Bladder Cancer
  • Kidney Cancer
  • Stomach Cancer
  • Colorectal Cancer
  • Pancreas Cancer
  • Liver Cancer
  • Skin Cancer