Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT04825834
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2021-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)
Sponsor:
Delfi Diagnostics Inc.
Organization:
Study Overview
Official Title:
DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DELFI-L101
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: