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

NCT05374044 | Unknown

• 1 other identifier: SF2020-1-2151
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

rectal cancer; neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• pathological tumor regression grade(pTRG)

  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.

  within 2 weeks after surgery

Secondary Outcomes (3)

• distant metastasis

  3 years from the data of surgery

• Death

  3 years from the data of surgery

• local recurrence

  3 years from the data of surgery

Study Arms (1)

rectal cancer with NAT

The patients are planned to receive neoadjvant therapy, and then receive radical surgery.

Diagnostic Test: pelvic MRI for establishing new mrTRG method

Interventions

pelvic MRI for establishing new mrTRG method DIAGNOSTIC_TEST

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.

rectal cancer with NAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

biopsy-proved primary locally advanced rectal adenocarcinoma(cT3 and/or cN+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Capital's Funds for Health Improvement and Research (2020-1- 2151).: collaborator

Study Sites (3)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Peking University Shougang Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ying-Shi Sun, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: May 13, 2022
• Study Start: May 18, 2020
• Primary Completion: April 30, 2023
• Study Completion: December 31, 2025
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (3)