NCT06941987尚未招募不适用
Evaluate the Clinical Feasibility of a Novel Neoantigen-Reactive CD8+ T Cell (NART) Detection Technology for Postoperative MRD Surveillance of Pancreatic Cancer
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The correlation between NART detection and recurrence-free survival
研究概览
简要总结
The goal of this observational study is to learn about the diagnostic performance of a novel Neoantigen-Reactive CD8+ T cell (NART) technology detecting minimal residual disease (MRD) in postoperative surveillance of pancreatic cancer. The main question it aims to answer is: Is NART a sensitive and accurate detection for MRD? Participants are required to undergo periodic blood sampling and imaging examinations as the protocol specifies.
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
- •Assessd as resectable PDAC before surgical procedure
- •Voluntary to donate tumor samples resected in curative surgery for PDAC
- •Voluntary to participate in the radiological evaluation, tests of serum tumor markers, and the collection of MRD samples according to the study protocol
- •ECOG state (PS) grades ≤ 2
- •Voluntary to sign informed consent and adhering to the requirements and limitations outlined by lCD and this protocol
- •Confimed as pancreatic ductal adenocarcinoma by pathology
- •RO or R1 resection
- •Clinically evalutated eligible for adjuvant therapy
- •Tumor tissue samples meet the requirements of whole exome sequencing (WES)
排除标准
- •Preoperative imaging examinations show distant metastasis
- •Have received neoadjuvant therapy
- •Have any other active malignancy within 5 years before enrollment, or have any other indolent cancers that did not interfere with the primary cancer assessment in the study without prior approval from the research committee
- •With other physical or mental conditions that may increase the risk of study participation or (in the investigator's judgment) may make the subject ineligible for study participation, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormalities
- •Have participated in other interventional or observational clinical studies
结局指标
主要结局
The correlation between NART detection and recurrence-free survival
时间窗: From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months
次要结局
- The correlation between conventional ct-DNA test and RFS(From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months)
- The correlation between serum markers and RFS(From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months)
- The correlation between NART detection and overall survival (OS)(From date of surgery until the date of death, assessed 3 months thereafter up to 60 months)
- The correlation between conventional ct-DNA test and OS(From date of surgery until the date of death, assessed 3 months thereafter up to 60 months)
- The correlation between serum markers and OS(From date of surgery until the date of death, assessed 3 months thereafter up to 60 months)
- The diagnostic performance of NART detection(From the date of first enrollment until the study completion, an average of 30 months.)
- The diagnostic performance of conventional ct-DNA test.(From the date of first enrollment until the study completion, an average of 30 months.)
- The diagnostic performance of serum markers.(From the date of first enrollment until the study completion, an average of 30 months.)
研究者
研究点 (1)
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