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

Colorectal Cancer Clinical Trial

— DELFI-L101  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04825834
• Other study ID #: DELFI-L101 Study
• Status: Recruiting
• Start date: March 22, 2021
• Est. completion date: May 31, 2026

Study information

• Verified date: June 2024
• Source: Delfi Diagnostics Inc.
• Contact: Sonali Kotagiri
• Phone: (667) 930-4983
• Email: clindev[@]delfidiagnostics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2660
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

All Participants:

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 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)

OR Planned thoracic imaging (CT) as part of standard of care within 6 weeks 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)

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, skin (excluding cutaneous basal cell and squamous cell carcinoma) 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 judgment with planned treatment and no prior systemic therapy, definitive therapy, radiation, or surgical resection.

OR Clinically (based on imaging and clinical judgment) or pathologically confirmed non-invasive or invasive bladder cancer with planned treatment and no prior systemic therapy, definitive therapy, radiation or surgical resection.

Exclusion Criteria:

All Participants:

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 participant'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 any DELFI sponsored study

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Delfi Diagnostics Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mazzone PJ, Bach PB, Carey J, Schonewolf CA, Bognar K, Ahluwalia MS, Cruz-Correa M, Gierada D, Kotagiri S, Lloyd K, Maldonado F, Ortendahl JD, Sequist LV, Silvestri GA, Tanner N, Thompson JC, Vachani A, Wong KK, Zaidi AH, Catallini J, Gershman A, Lumbard — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of lung cancer detection measured by sensitivity, specificity, and the AUC of the ROC.		Approximately 12 months
Secondary	Accuracy (sensitivity and specificity) in clinical subgroups of interest		Approximately 12 months
Secondary	Prevalence-based measures, including positive predictive value (PPV), negative predictive value (NPV), and number needed to screen (NNS)		Approximately 12 months
Secondary	Accuracy of tumor of origin (confusion matrix of predicted versus actual cancer type)		Approximately 12 months
Secondary	Adverse events (AEs) associated with the blood specimen collection		Point in time of blood specimen collection (1day) at enrollment
Secondary	Expected distribution of the DELFI score in the intended use population and clinical subgroups of interest		Approximately 12 months
Secondary	Association of genomic features with clinical subgroups of interest		Approximately 12 months
Secondary	Analytical performance (e.g. repeatability/reproducibility)		Approximately 12 months
Secondary	Accuracy of multi-cancer detection measured by sensitivity, specificity, and the AUC of the ROC and tissue of origin (TOO) accuracy		Approximately 12 months