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

Peking University Cancer Hospital & Institute

Status

Active, not recruiting

Conditions

Rectal Cancer

Treatments

Diagnostic Test: pelvic MRI for establishing new mrTRG method

Study type

Observational

Funder types

Other

Identifiers

NCT05374044

SF2020-1-2151

Details and patient eligibility

About

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 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.

Enrollment

385 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)