Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06166147
Status:
RECRUITING
Last Update Posted:
2023-12-12
First Post:
2023-11-07
Brief Title:
A Prospective Study of Liquid Biopsy for Pancreatic Cancer Early Detection
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Proof of Concept Study of Pancreatic Cancer Early Detection by cfDNA Assay
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This study is a multi-center observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from clinically-annotated individuals
Detailed Description:
Peripheral blood samples from participants with new diagnosis of pancreatic cancers will be collected to characterize the cancer-specific circulating signals by sequencing cell free DNA A noninvasive test integrating machine learning algorithm will be trained and validated through a two-stage approach in recruited well-classified individuals along with non-cancers without clinical diagnosis of cancer after routine medical screening The performance of liquid biospy assays discovering cancer from non-cancer will be evaluated in participants with benign disease as well as average risk individuals
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None