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

• ClinicalTrials.gov Identifier: NCT04825834
• Recruitment Status: Recruiting
• First Posted: April 1, 2021
• Last Update Posted: November 29, 2022
• Sponsor: Delfi Diagnostics Inc.
• Information provided by (Responsible Party): Delfi Diagnostics Inc.

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

Study Design

• Study Type: Observational
• Estimated 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: March 22, 2021
• Estimated Primary Completion Date: July 31, 2023
• Estimated Study Completion Date: March 31, 2024

Groups and Cohorts

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.

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

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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)

   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 that meet the following criteria:

7. Pathologic confirmed, invasive non-lung cancer diagnosis, originating from the esophagus (upper), colon or rectum, pancreas, stomach (including lower esophagus), head and neck, bladder, kidney, or liver, with no prior systemic therapy, definitive therapy, radiation, or surgical resection. OR Clinically confirmed invasive non-lung cancer diagnosis originating from the pancreas, kidney, or liver, based on imaging and clinical judgement with planned treatment and 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
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. Enrollment in the DELFI-L201 study

Contacts and Locations

Contacts

Contact: Ashley Birch; (917) 781-3727; clindev@delfidiagnostics.com

Locations

United States, New York

Memorial Sloan Kettering Cancer Center; Recruiting

New York, New York, United States, 10065

Contact: Luke RG Pike, MD, DPhil

United States, Ohio

The Cleveland Clinic Foundation; Recruiting

Cleveland, Ohio, United States, 44195

Contact: Peter Mazzone, MD

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

More Information

• Responsible Party: Delfi Diagnostics Inc.
• ClinicalTrials.gov Identifier: NCT04825834
• Other Study ID Numbers: DELFI-L101 Study
• First Posted: April 1, 2021
• Last Update Posted: November 29, 2022
• Last Verified: November 2022

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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urologic Diseases; Male Urogenital Diseases; Kidney Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Stomach Diseases