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History of Changes for Study: NCT04825834
DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study) (DELFI-L101)
Latest version (submitted June 1, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 30, 2021 None (earliest Version on record)
2 April 8, 2021 Contacts/Locations and Study Status
3 August 24, 2021 Contacts/Locations and Study Status
4 February 15, 2022 Study Status, Contacts/Locations, Outcome Measures, Eligibility, Study Design and Conditions
5 June 1, 2022 Contacts/Locations and Study Status
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Study NCT04825834
Submitted Date:  March 30, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: DELFI-L101 Study
Brief Title: DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study) (DELFI-L101)
Official Title: DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2021
Overall Status: Recruiting
Study Start: March 22, 2021
Primary Completion: March 31, 2023 [Anticipated]
Study Completion: March 31, 2023 [Anticipated]
First Submitted: March 29, 2021
First Submitted that
Met QC Criteria:
March 30, 2021
First Posted: April 1, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
March 30, 2021
Last Update Posted: April 1, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Delfi Diagnostics Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
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.
Open or close this module Conditions
Conditions: Lung Cancer
Head and Neck Cancer
Esophageal Cancer
Bladder Cancer
Kidney Cancer
Stomach Cancer
Colorectal Cancer
Pancreas Cancer
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Control
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: Residual blood specimens may be used to develop and evaluate performance of biomarker assays to detect cancers or other conditions, laboratory process improvements, and proficiency testing. Residual blood specimens will be de-identified and will be stored for no more than 20 years.
Enrollment: 1700 [Anticipated]
Number of Groups/Cohorts 3
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Individuals eligible for Lung Cancer screening with Lung Cancer diagnosis
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
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
Blood Sample Collection
Subjects enrolled in the DELFI-L101 will have blood specimens collected (~40 mL) at enrollment.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Accuracy of lung cancer detection measured by sensitivity, specificity, and the AUC of the ROC.
[ Time Frame: Approximately 12 months ]

Secondary Outcome Measures:
1. Accuracy (sensitivity and specificity) in clinical subgroups of interest
[ Time Frame: Approximately 12 months ]

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

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

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

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

Open or close this module Eligibility
Study Population: Individuals ≥ 50 years of age who are eligible for lung cancer screening from medical, surgical, sub- specialty clinics, lung cancer screening, lung nodule, thoracic surgery, and chest clinic practices.
Sampling Method: Non-Probability Sample
Minimum Age: 50 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers:
Criteria:

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)

    AND

    Inclusion Group 1: High Risk Patients that meet criteria 5 and 6 below:

  5. 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

  6. Meet one of the criteria below:
    1. No suspected or confirmed lung cancer diagnosis OR
    2. Suspected of lung cancer OR
    3. Confirmed, untreated lung cancer

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

  7. Pathologic confirmed, solid-tumor cancer diagnosis, that is not lung cancer or non-melanoma skin cancer, with no prior systemic therapy, definitive therapy, radiation, or surgical resection.

Exclusion Criteria:

All Subjects:

  1. History of previous cancer or therapy for cancer within the year prior to enrollment
  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
Open or close this module Contacts/Locations
Central Contact Person: Shanna Allen
Telephone: 682-800-2025
Email: allen@delfidiagnostics.com
Study Officials: Peter Mazzone, MD, MPH
Principal Investigator
The Cleveland Clinic
Locations: United States, Florida
Precision for Medicine
[Recruiting]
Loxahatchee Groves, Florida, United States, 33470
Contact:Contact: Missy Farrell missy.farrell@precisionformedicine.com
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Individual participant data that underline the results reported in publications of the study may be shared after de-identification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, and informed consent form will also be shared. Data may be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
Open or close this module References
Citations:
Links:
Available IPD/Information:

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