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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

385 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-18

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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rectal cancer with NAT

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

pelvic MRI for establishing new mrTRG method

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No