Clinical trial NCT05374044: Establishment of MRI Model for pTRG in Rectal Cancer With Establishment of
Official title: Establishment of a Quantified Imaging Method for Evaluating Tumor Response Grade in Rectal Cancer Patient With Neoadjuvant Therapy: a Multi-center Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rectal Cancer
Keywords: rectal cancer
neoadjuvant therapy
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Capital's Funds for Health Improvement and Research (2020-1- 2151).
First posted: 2022-05-13
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: biopsy-proved primary locally advanced rectal adenocarcinoma(cT3 and/or cN+)

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.

Eligibility criteria: 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)

Primary outcomes:
measure: pathological tumor regression grade(pTRG)
timeFrame: within 2 weeks after surgery
Secondary outcomes:
measure: distant metastasis
timeFrame: 3 years from the data of surgery
measure: Death
timeFrame: 3 years from the data of surgery
measure: local recurrence
timeFrame: 3 years from the data of surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Ying-Shi Sun, MD
role: PRINCIPAL_INVESTIGATOR
References: