Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151691
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-11-22
Brief Title:
Assessment of Early Pancreatic Cancer Prognosis by Minimal Residual Disease Using Multi-omics Approach
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Explorations of Cell-free DNA Multi-omics Technology in Detection of Minimal Residual Disease and Disease Prognosis After Surgery in Early Pancreatic Ductal Adenocarcinoma A Single-center Prospective Observational Case Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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 trial aims to develop a minimal residual disease MRD detection model for predicting recurrence of patients with stage I-II pancreatic ductal adenocarcinoma after surgery and adjuvant therapy based on cfDNA fragmentation and methylation signal
Detailed Description:
The entire study is divided into two stages Stage one is the enrollment period 51 subjects with pancreatic ductal adenocarcinoma in stages I-II who have not received neoadjuvant therapy and have undergone radical surgery were enrolled Blood samples at the time point before surgical treatment T0 were collected and fresh tissue specimens cancerous tissue and adjacent normal tissue were collected Blood samples were subjected to methylation fragment group and CNV multi-omics testing and tissue samples were subjected to target methylation area testing Stage two is the follow-up period Blood samples from the fifth week after surgery to before adjuvant therapy T1 and blood samples from 4-8 weeks after adjuvant therapy T2 were collected Blood samples were subjected to methylation fragment group and CNV multi-omics testing with different techniques The subjects were followed up for 15 years According to progression and recurrence the subjects were divided into progression group and non-progression group Methylation and multi-omics prognosis models were trained and compared for their performance in residual detection and recurrence prediction
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