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

Sponsor
Delfi Diagnostics Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04825834
Collaborator
(none)
2,500
2
36.3
1250
34.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood Sample Collection

Detailed Description

Subjects will be enrolled into the DELFI-L101 study after informed consent and eligibility is confirmed. At enrollment, subjects will have blood specimens collected (~40 mL) and 12 months post-enrollment their medical records will be reviewed.

Study Design

Study Type:
Observational
Anticipated Enrollment :
2500 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)
Actual Study Start Date :
Mar 22, 2021
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Individuals eligible for Lung Cancer screening with Lung Cancer diagnosis

Other: Blood Sample Collection
Subjects enrolled in the DELFI-L101 will have blood specimens collected (~40 mL) at enrollment.

Individuals eligible for Lung Cancer screening with no cancer diagnosis

Other: Blood Sample Collection
Subjects enrolled in the DELFI-L101 will have blood specimens collected (~40 mL) at enrollment.

Individuals eligible for Lung Cancer screening with Non-Lung Cancer diagnosis

Other: Blood Sample Collection
Subjects enrolled in the DELFI-L101 will have blood specimens collected (~40 mL) at enrollment.

Outcome Measures

Primary Outcome Measures

  1. Accuracy of lung cancer detection measured by sensitivity, specificity, and the AUC of the ROC. [Approximately 12 months]

Secondary Outcome Measures

  1. Accuracy (sensitivity and specificity) in clinical subgroups of interest [Approximately 12 months]

  2. Accuracy of tumor of origin (confusion matrix of predicted versus actual cancer type) [Approximately 12 months]

  3. Adverse events (AEs) associated with the blood specimen collection [Point in time of blood specimen collection (1day) at enrollment]

  4. Expected distribution of the DELFI score in the intended use population [Approximately 12 months]

  5. Analytical performance (e.g. repeatability/reproducibility) [Approximately 12 months]

  6. Accuracy of multi-cancer detection measured by sensitivity, specificity, and the AUC of the ROC and tissue of origin (TOO) accuracy [Approximately 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
All Subjects:
  1. Ability to understand and provide written informed consent

  2. Age ≥ 50 years

  3. Current or Former Smoker

  4. ≥ 20 pack-years (pack years = number of packs per day X number of years smoked)

Inclusion Group 1: High Risk Patients that meet criteria 5 and 6 below:
  1. Prior thoracic imaging (computed tomography (CT)) within 12 months of enrollment OR Planned thoracic imaging (CT) as part of standard of care within 6 weeks of enrollment

AND

  1. Meet one of the criteria below:

  2. No suspected or confirmed lung cancer diagnosis OR

  3. Suspected of lung cancer OR

  4. Confirmed, untreated lung cancer

Inclusion Group 2: High Risk Patients with cancer other than lung cancer that meet the following criteria:

  1. Pathologic confirmed, invasive cancer diagnosis, that is not lung cancer with no prior systemic therapy, definitive therapy, radiation, or surgical resection.
Exclusion Criteria:
All Subjects:
  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. Any history of hematologic malignancies or myelodysplasia

  3. Any history of organ tissue transplantation

  4. Any history of blood product transfusion

  5. Current pregnancy

  6. Any condition that in the opinion of the Investigator should preclude the subject's participation in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065
2 The Cleveland Clinic Foundation Cleveland Ohio United States 44195

Sponsors and Collaborators

  • Delfi Diagnostics Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Delfi Diagnostics Inc.
ClinicalTrials.gov Identifier:
NCT04825834
Other Study ID Numbers:
  • DELFI-L101 Study
First Posted:
Apr 1, 2021
Last Update Posted:
Jun 2, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2022