Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422637
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-14
Brief Title:
A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy
Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Organization:
The First Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
INFORM A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 project aims to establish the MERCURY pilot screening program as part of the Love Lung Project employing a novel concept of lung cancer screening with the assistance of low-dose computer tomography LDCT By using clinical pathology as the gold standard it will parallelly compare the performance with a sensitivity of 90 of the MERCURY early lung cancer screening model against the LDCT-only screening group within the Love Lung Project Ultimately the objective is to reduce the proportion of overtreatment achieve earlier staging and extend patient survival thus enhancing clinical value
Detailed Description:
This study is the first international prospective interventional study for lung cancer screening It designates the Love Lung Program using Low-Dose Computed Tomography LDCT screening as the control group and the MERCURY screening group as the intervention group Participants from the general population were enrolled and randomly assigned to either group in a 11 ratio The MERCURY group plans to collect baseline peripheral blood samples from 2972 individuals for whole genome sequencing WGS based on plasma circulating free DNA cfDNA This will facilitate a comprehensive analysis of the fragmentomics characteristics of cfDNA Through the MERCURY early lung cancer screening model individuals potentially at early stages of lung cancer will be identified Those showing positive signs will subsequently undergo sequential LDCT to further confirm lung cancer status eventually confirmed via surgery or pathology To minimize ethical risks the negative cases will receive additional LDCT after three months to further confirm their lung status The control group under the Love Lung Program will follow standard LDCT screening procedures with the same number of participants those with positive LDCT results will undergo clinical diagnosis while those with negative results will only be followed up for lung status Relying on the Love Lung Program the objective is to establish a new concept of lung cancer screening that precedes with MERCURY screening assisted by LDCT diagnostics
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