跳至主要内容
临床试验/NCT06435767
NCT06435767招募中不适用

Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy: A Retrospective Cohort Study

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
The role of adjuvant chemotherapy(ACT)

研究概览

简要总结

Ampullary cancer, a rare malignancy, lacks standardized guidelines for effective multimodal treatment following curative resection. The opinions on whether postoperative chemotherapy can improve the long-term survival of ampullary adenocarcinoma (AA) are discordant. This aspect remains poorly studied, with comparably scant research conducted on it.

log odds of positive lymph nodes (LODDS), a quantitative variable, can continuously and accurately reflect the burden of nodal involvement, which suggested a potential ability to identify AA patients benefiting from postoperative adjuvant chemotherapy (ACT). Therefore, Mainly focused issues of ACT addressed in the study are as follows: 1) the role of ACT in improving long-term survival for patients with AA after curative resection. 2) the role of LODDS in identifying postoperative AA patients benefiting from ACT. 3) compared with T and N classifications reported previously, the advantage of LODDS in identifying ACT-benefited patients.

In this cohort study, a large scale of sample size was conducted by drawing on the collective experience of the National Cancer Center of China. The patients treated with radiotherapy were excluded to concentrate on the effect of ACT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pathologically confirmed AA patients without distant metastasis treated with curative-intent resection

排除标准

  • patients who received neoadjuvant therapy or radiotherapy, as well as those with missing clinical pathological or follow-up information

结局指标

主要结局

The role of adjuvant chemotherapy(ACT)

时间窗: 1 year

The association between ACT and Overall Survival (OS) of patients

次要结局

  • The role of adjuvant chemotherapy(ACT)(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Bing Zhao

Deputy director

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (1)

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