Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589388
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ctDNA Monitoring to Predict the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective observational study with three primary objectives
Objective 1 Evaluate the detection rate and changes in circulating tumor DNA ctDNA levels in blood samples from colorectal cancer patients before during and after total neoadjuvant therapy TNT
Determine the detection rate and change of CtDNA in blood samples of cancer patients before during and after TNT then assess changes in ctDNA expression within the study population during treatment
Determine the ctDNA positivity rate before treatment
Determine the ctDNA positivity rate during TNT
Determine the ctDNA positivity rate after TNT and assess ctDNA level changes during treatment
Objective 2 Investigate the relationship between ctDNA expression and MRICT scan imaging with the pathological complete response pCR to neoadjuvant therapy
Correlation between ctDNA detection and pCRTRGNAR score Calculate the Positive Prediction Value - PPV Negative Prediction Value - NPV of ctDNA
Correlation between MRICT scan imaging and pCR Calculate the PPV and NPV of MRICT scan
Combination of ctDNA detection and MRICT scan imaging to predict pCR Calculate the PPV and NPV of the combined markers
Objective 3 Evaluate the relationship between post-TNT ctDNA expression and disease-free survival in colorectal cancer patients
Objective 1 Evaluate the detection rate and changes in circulating tumor DNA ctDNA levels in blood samples from colorectal cancer patients before during and after total neoadjuvant therapy TNT
Determine the detection rate and change of CtDNA in blood samples of cancer patients before during and after TNT then assess changes in ctDNA expression within the study population during treatment
Determine the ctDNA positivity rate before treatment
Determine the ctDNA positivity rate during TNT
Determine the ctDNA positivity rate after TNT and assess ctDNA level changes during treatment
Objective 2 Investigate the relationship between ctDNA expression and MRICT scan imaging with the pathological complete response pCR to neoadjuvant therapy
Correlation between ctDNA detection and pCRTRGNAR score Calculate the Positive Prediction Value - PPV Negative Prediction Value - NPV of ctDNA
Correlation between MRICT scan imaging and pCR Calculate the PPV and NPV of MRICT scan
Combination of ctDNA detection and MRICT scan imaging to predict pCR Calculate the PPV and NPV of the combined markers
Objective 3 Evaluate the relationship between post-TNT ctDNA expression and disease-free survival in colorectal cancer patients
Detailed Description:
This is a prospective observational study conducted at the Medical Genetics Institute MGI in collaboration with 3 hospitals 175 Military Hospital Nguyen Tri Phuong Hospital and 108 Military Central Hospital Participants must meet all inclusion criteria and no exclusion criteria detailed in the eligibility section
Sample Collection
10 mL of peripheral blood Streck tubes is collected for ctDNA analysis at 3 time points pre-TNT at diagnosis middle of treatment after chemoradiotherapy or after chemotherapy and post-TNT before surgery
6-8 slides 6um thicknessslide of FFPE biopsy tumor samples before treatment
6-8 slides 6um thicknessslide of FFPE tumor samples collected after surgery This sample is used to compare the mutational profiles with the corresponding biopsy samples
Clinical results for collection
Age sex medical history
Number size and stage TNM of tumor
MRI andor CT scan images and reports at pre-treatment mid-treatment and end-treatment before surgery
Histopathological evaluation of biopsy and surgery tissues and conclusion of pathological response
TNM classification pCR conclusion
TRG conclusion
Disease-free survival follow-up for 2 years
Sample Collection
10 mL of peripheral blood Streck tubes is collected for ctDNA analysis at 3 time points pre-TNT at diagnosis middle of treatment after chemoradiotherapy or after chemotherapy and post-TNT before surgery
6-8 slides 6um thicknessslide of FFPE biopsy tumor samples before treatment
6-8 slides 6um thicknessslide of FFPE tumor samples collected after surgery This sample is used to compare the mutational profiles with the corresponding biopsy samples
Clinical results for collection
Age sex medical history
Number size and stage TNM of tumor
MRI andor CT scan images and reports at pre-treatment mid-treatment and end-treatment before surgery
Histopathological evaluation of biopsy and surgery tissues and conclusion of pathological response
TNM classification pCR conclusion
TRG conclusion
Disease-free survival follow-up for 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None