Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05904665
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-06-06
Brief Title:
Circulating Tumor DNA Methylation Guided Postoperative Follow-up Strategy for Non-metastatic Colorectal Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Circulating Tumor DNA Methylation Guided Postoperative Follow-up Strategy for Non-metastatic Colorectal Cancer a Multicenter Prospective Randomized Controlled Cohort Study FIND Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Colorectal cancer CRC is one of the most common gastrointestinal tumors According to the latest cancer report the incidence and mortality rates of CRC are both ranked top 5 among malignant tumors worldwide and continue to rise Patients who receive treatment in the early stage stage I have a 5-year survival rate of approximately 90 However for high-risk stage II and III colorectal cancer patients the 5-year survival rate is only 40-70 and almost half of the patients experience postoperative recurrence and metastasis
Circulating tumor DNA ctDNA is a small fraction of total cell-free DNA cfDNA in peripheral blood circulation carrying tumor-specific genetic and epigenetic information It can usually be detected in the serum or plasma of tumor patients in peripheral blood Studies have shown that methylation detection of plasma ctDNA can be used for predicting the efficacy and prognosis of tumor postoperatively as well as for dynamic monitoring
Current methods for monitoring CRC recurrence include testing for carcinoembryonic antigen CEA in blood and periodic computed tomography CT scans However due to the low sensitivity of CEA and the radiation and cost limitations of CT examination the disease status of postoperative CRC patients cannot be well-monitored
ctDNA is a promising biomarker for monitoring the recurrence and metastasis of CRC Research results have shown that ctDNA can be detected in nearly all subjects before surgery and the changes in ctDNA levels are related to the extent of surgical resection The detection of ctDNA after surgery generally indicates recurrence within one year ctDNA may be a more reliable and sensitive indicator than the current standard biomarker CEA providing a window for early intervention
This multicenter prospective and randomized controlled cohort study uses a single-tube methylation-specific quantitative PCR mqMSP detection which detects 10 different methylation markers and can quantitatively analyze plasma samples containing tumor DNA as low as 005 This study will use the ctDNA methylation detection technology to conduct quantitative detection of ctDNA methylation in the plasma of enrolled patients hoping to predict the recurrence and metastasis risk of patients at an earlier stage through ctDNA changes and to explore the value of ctDNA detection in guiding postoperative follow-up for non-metastatic CRC
Circulating tumor DNA ctDNA is a small fraction of total cell-free DNA cfDNA in peripheral blood circulation carrying tumor-specific genetic and epigenetic information It can usually be detected in the serum or plasma of tumor patients in peripheral blood Studies have shown that methylation detection of plasma ctDNA can be used for predicting the efficacy and prognosis of tumor postoperatively as well as for dynamic monitoring
Current methods for monitoring CRC recurrence include testing for carcinoembryonic antigen CEA in blood and periodic computed tomography CT scans However due to the low sensitivity of CEA and the radiation and cost limitations of CT examination the disease status of postoperative CRC patients cannot be well-monitored
ctDNA is a promising biomarker for monitoring the recurrence and metastasis of CRC Research results have shown that ctDNA can be detected in nearly all subjects before surgery and the changes in ctDNA levels are related to the extent of surgical resection The detection of ctDNA after surgery generally indicates recurrence within one year ctDNA may be a more reliable and sensitive indicator than the current standard biomarker CEA providing a window for early intervention
This multicenter prospective and randomized controlled cohort study uses a single-tube methylation-specific quantitative PCR mqMSP detection which detects 10 different methylation markers and can quantitatively analyze plasma samples containing tumor DNA as low as 005 This study will use the ctDNA methylation detection technology to conduct quantitative detection of ctDNA methylation in the plasma of enrolled patients hoping to predict the recurrence and metastasis risk of patients at an earlier stage through ctDNA changes and to explore the value of ctDNA detection in guiding postoperative follow-up for non-metastatic CRC
Detailed Description:
None
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