Establishment of MRI Model for pTRG in Rectal Cancer With Establishment of

Overview

This study proposeto integrate a variety of imaging quantitative indicators to establish a new MRI-based tumor response regression(mrTRG) classification method. The accuracy of the established mrTRG classification method according pathology TRG(pTRG) will be tested. The ability of the established mrTRG classification method to predict prognosis will also be tested.

Full Title of Study: “Establishment of a Quantified Imaging Method for Evaluating Tumor Response Grade in Rectal Cancer Patient With Neoadjuvant Therapy: a Multi-center Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2023

Detailed Description

The study included two part: one is a retrospective single-center cohort for analyzing quantitative MRI factors associated with pTRG, from which a new MRI-based tumor response regression(mrTRG) classification method will be established. The other is a prospective multi-center cohort for testing the accuracy of the established mrTRG classification according to pTRG; and also for validating the established mrTRG classification associated with survival.

Interventions

  • Diagnostic Test: pelvic MRI for establishing new mrTRG method
    • they will received two pelvic MR examinations before and after neoadjvant therapy. The MRI before neoadjvant therapy is considered as baseline MRI, which is usually taken within 3 weeks before NAT. The MRI after neoadjvant therapy is considered as preoperative MRI, which is usually taken within 3-8 weeks before NAT.

Arms, Groups and Cohorts

  • rectal cancer with NAT
    • The patients are planned to receive neoadjvant therapy, and then receive radical surgery.

Clinical Trial Outcome Measures

Primary Measures

  • pathological tumor regression grade(pTRG)
    • Time Frame: within 2 weeks after surgery
    • pTRG is evaluated according to the AJCC system. pTRG0-1 is defined as good response, pTRG2 as moderate response, and pTRG3 as poor response. The pTRG is judged by two experienced pathologists working together. If there are any discrepancies, then a third senior pathologist is consulted for arbitration. there were any discrepancies, then a third senior pathologist was consulted. there were any discrepancies, then a third senior pathologist was consulted.

Secondary Measures

  • distant metastasis
    • Time Frame: 3 years from the data of surgery
    • Distant metastastic lesion detected by follow-up CT which will be performed every 3 month for the first two year and every 6 month since the third year
  • Death
    • Time Frame: 3 years from the data of surgery
    • all cause death
  • local recurrence
    • Time Frame: 3 years from the data of surgery

Participating in This Clinical Trial

Inclusion Criteria

  • biopsy-proved primary rectal cancer – baseline MRI confirmed LARC (cT3 and/or cN+) – scheduled to take neoadjuvant therapy – receive baseline and preoperative pelvic MRI – receive TME surgery after NAT – have routine follow-up after the operation Exclusion Criteria:

  • history of malignancy or multiple primary cancers – receive surgery directly without NAT – don't receive TME surgery – don't complete NAT – simultaneous distant metastasis at the baseline diagnosis – lack of baseline or preoperative pelvic MRI – incomplete or unavailable pathological information – lost to follow-up within three months after surgery (lost since the first follow-up visit)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Cancer Hospital
  • Collaborator
    • Capital’s Funds for Health Improvement and Research (2020-1- 2151).
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sun Ying-Shi, Professor – Beijing Cancer Hospital
  • Overall Official(s)
    • Ying-Shi Sun, MD, Principal Investigator, Beijing Cancer Hospital
  • Overall Contact(s)
    • Xiao-Ting Li, MPH, 861088196017, 13520120308@163.com

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