Ignite Creation Date:
2024-05-06 @ 2:09 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04227886
Status:
UNKNOWN
Last Update Posted:
2020-01-14
First Post:
2019-12-30
Brief Title:
Study on Predictive Biomarkers of Neoadjuvant Chemoradiotherapy for Rectal Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Prospective Observational Multicenter Study on Biomarkers for Predicting the Efficacy and Toxicities of Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer Based on Tissue and Plasma Exosome RNA
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
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:
Backgrounds A multicenter randomized phase III trial NCT02605265 proved that adding irinotecan guided by UGT1A1 to capecitabine-based neoadjuvant chemoradiotherapy significantly increases complete tumor response The treatment toxicities were increased but tolerable
Purposes This study aims to identify the predictive biomarkers from patients tumor biopsy samples and peripheral blood samples before neoadjuvant therapy for predicting the response and toxicities to neoadjuvant therapy to stratify patients and optimize treatment strategy
Purposes This study aims to identify the predictive biomarkers from patients tumor biopsy samples and peripheral blood samples before neoadjuvant therapy for predicting the response and toxicities to neoadjuvant therapy to stratify patients and optimize treatment strategy
Detailed Description:
OBJECTIVES
Primary
Establish a predictive model for response based on tissue RNA and plasma exosome RNA
Establish a predictive model for toxicities based on tissue RNA and plasma exosome RNA
Secondary
Internal validation of the established predictive models
External validation of the established predictive models
OUTLINE
-Treatment Patients receive neoadjuvant therapy and surgery per the protocol Samples collection Tumor tissue and peripheral blood will be collected prior to neoadjuvant therapy
-Grouping Response Patients will be dichotomized into two groups based on the TRG TRG of 0-1 is defined as good response TRG of 2-3 is defined as poor response
Toxicities Patients will be dichotomized into two groups based on the grade of AEs No grade 3-4 toxicities occurs during neoadjuvant therapy is defined as light toxicities Grade 3-4 toxicities occur during neoadjuvant therapy is defined as heavy toxicities
-Predictive Model Construction Using RNA sequencing method to obtain the whole genome transcription profiles of the tumor tissue and plasm exosome RNA Compare the gene expression differences between the two response groups and the two toxicity groups Predictive models of response and toxicities are constructed
-Internal Validation Patients treated at Fudan University Shanghai Cancer Center N50 per the protocol will be enrolled as the internal validation cohort Samples of tissue and plasm will be collected and analyzed The performance of the model will be evaluated by the correlation of the predicted responsetoxicities and the actual responsetoxicities
-External Validation Patients treated at Liaoning Cancer Hospital Institute N50 and Harbin Medical University Cancer Hospital N50 per the protocol will be enrolled as two external validation cohorts Samples of tissue and plasm will be collected and analyzed The performance of the model will be evaluated by the correlation of the predicted responsetoxicities and the actual responsetoxicities
Primary
Establish a predictive model for response based on tissue RNA and plasma exosome RNA
Establish a predictive model for toxicities based on tissue RNA and plasma exosome RNA
Secondary
Internal validation of the established predictive models
External validation of the established predictive models
OUTLINE
-Treatment Patients receive neoadjuvant therapy and surgery per the protocol Samples collection Tumor tissue and peripheral blood will be collected prior to neoadjuvant therapy
-Grouping Response Patients will be dichotomized into two groups based on the TRG TRG of 0-1 is defined as good response TRG of 2-3 is defined as poor response
Toxicities Patients will be dichotomized into two groups based on the grade of AEs No grade 3-4 toxicities occurs during neoadjuvant therapy is defined as light toxicities Grade 3-4 toxicities occur during neoadjuvant therapy is defined as heavy toxicities
-Predictive Model Construction Using RNA sequencing method to obtain the whole genome transcription profiles of the tumor tissue and plasm exosome RNA Compare the gene expression differences between the two response groups and the two toxicity groups Predictive models of response and toxicities are constructed
-Internal Validation Patients treated at Fudan University Shanghai Cancer Center N50 per the protocol will be enrolled as the internal validation cohort Samples of tissue and plasm will be collected and analyzed The performance of the model will be evaluated by the correlation of the predicted responsetoxicities and the actual responsetoxicities
-External Validation Patients treated at Liaoning Cancer Hospital Institute N50 and Harbin Medical University Cancer Hospital N50 per the protocol will be enrolled as two external validation cohorts Samples of tissue and plasm will be collected and analyzed The performance of the model will be evaluated by the correlation of the predicted responsetoxicities and the actual responsetoxicities
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