Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06231953
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-05-18
Brief Title:
A Prospective Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
A Prospective Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-01
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 is a prospective multi-center clinical study of Multi-Cancer Early Detection MCED testing in cancer patients and healthy volunteers The purpose of this study is to establish MCED platform through the analysis of whole genome sequencing of circulating DNA
The study will enroll 4000 subjects as defined by eligibility criteria at up to 10 clinical institutions in South Korea
The study will enroll 4000 subjects as defined by eligibility criteria at up to 10 clinical institutions in South Korea
Detailed Description:
AIMA is analysing whole genome sequencing data of circulating tumor DNA combined through machine learning technique to develop MCED platform to detect early stage cancer
The purpose of this prospective multi-center observational study is to validate an MCED platform for the early detection of cancers
The investigators will collect blood samples from subjects who are diagnosed as invasive cancers before treatment or from healthy volunteers
The purpose of this prospective multi-center observational study is to validate an MCED platform for the early detection of cancers
The investigators will collect blood samples from subjects who are diagnosed as invasive cancers before treatment or from healthy volunteers
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