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

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ClinicalTrials.gov Identifier: NCT04825834
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Delfi Diagnostics Inc.

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
Lung Cancer Head and Neck Cancer Esophageal Cancer Bladder Cancer Kidney Cancer Stomach Cancer Colorectal Cancer Pancreas Cancer 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.

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Study Type : Observational
Estimated Enrollment : 1700 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 : March 22, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023


Group/Cohort 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.




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 ]

Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04825834


Contacts
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Contact: Shanna Allen 682-800-2025 allen@delfidiagnostics.com

Locations
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United States, Florida
Advance Pulmonary Research Institute Recruiting
Loxahatchee Groves, Florida, United States, 33470
Contact: Neal Warshoff, Dr       apridrw@gmail.com   
Sponsors and Collaborators
Delfi Diagnostics Inc.
Investigators
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Principal Investigator: Peter Mazzone, MD, MPH The Cleveland Clinic
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Responsible Party: Delfi Diagnostics Inc.
ClinicalTrials.gov Identifier: NCT04825834    
Other Study ID Numbers: DELFI-L101 Study
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Kidney Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urologic Diseases
Kidney Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases