Establishment of MRI Model for pTRG in Rectal Cancer With Establishment of
- Conditions
- Rectal Cancer
- Interventions
- Diagnostic Test: pelvic MRI for establishing new mrTRG method
- Registration Number
- NCT05374044
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 385
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description rectal cancer with NAT pelvic MRI for establishing new mrTRG method The patients are planned to receive neoadjvant therapy, and then receive radical surgery.
- Primary Outcome Measures
Name Time Method pathological tumor regression grade(pTRG) 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 Outcome Measures
Name Time Method local recurrence 3 years from the data of surgery distant metastasis 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 3 years from the data of surgery all cause death
Trial Locations
- Locations (3)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Peking University Shougang Hospital
🇨🇳Beijing, Beijing, China