Establishment of a Quantified Imaging Method for Evaluating Tumor Response Grade in Rectal Cancer Patient With Neoadjuvant Therapy: a Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 385
- 试验地点
- 3
- 主要终点
- pathological tumor regression grade(pTRG)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
pathological tumor regression grade(pTRG)
时间窗: 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.
次要结局
- local recurrence(3 years from the data of surgery)
- distant metastasis(3 years from the data of surgery)
- Death(3 years from the data of surgery)
研究者
Sun Ying-Shi
Professor
Peking University Cancer Hospital & Institute