Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Capital's Funds for Health Improvement and Research (2020-1- 2151). | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rectal cancer with NAT | The patients are planned to receive neoadjvant therapy, and then receive radical surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| distant metastasis | 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 | 3 years from the data of surgery |
| Death |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
biopsy-proved primary locally advanced rectal adenocarcinoma(cT3 and/or cN+)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ying-Shi Sun, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100039 | China | ||
| Beijing Cancer Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
|
all cause death
| 3 years from the data of surgery |
| local recurrence | 3 years from the data of surgery |
| Beijing |
| Beijing Municipality |
| 100142 |
| China |
| Peking University Shougang Hospital | Beijing | Beijing Municipality | 100142 | China |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |