Lung Cancer Clinical Trial

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

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.

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Full 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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Eligibility Criteria

Inclusion Criteria:

All Subjects:

Ability to understand and provide written informed consent
Age ≥ 50 years
Current or Former Smoker

≥ 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:

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

Meet one of the criteria below:

No suspected or confirmed lung cancer diagnosis OR
Suspected of lung cancer OR
Confirmed, untreated lung cancer

Inclusion Group 2: High Risk Patients that meet the following criteria:

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:

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)
Any history of hematologic malignancies or myelodysplasia
Any history of organ tissue transplantation
Any history of blood product transfusion
Current pregnancy
Any condition that in the opinion of the Investigator should preclude the subject's participation in the study
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)
Enrollment in the DELFI-L201 study

Study is for people with:

Lung Cancer

Estimated Enrollment:

2500

Study ID:

NCT04825834

Recruitment Status:

Recruiting

Sponsor:

Delfi Diagnostics Inc.

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There are 2 Locations for this study

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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Luke RG Pike, MD, DPhil
Contact
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Peter Mazzone, MD
Contact

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

2500

Study ID:

NCT04825834

Recruitment Status:

Recruiting

Sponsor:


Delfi Diagnostics Inc.

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