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临床试验/NCT06314971
NCT06314971已完成不适用

Predicting Recurrence After Curative-Intent Resection of T1 Colorectal Cancer With Transcriptomics

City of Hope Medical Center3 个研究点 分布在 3 个国家目标入组 138 人开始时间: 2023年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
138
试验地点
3
主要终点
Recurrence-free Survival

研究概览

简要总结

Tumor recurrence significantly affects survival rates following the local resection of submucosal colorectal cancers (T1 CRC). Despite this, there are currently no reliable biomarkers established to predict recurrence in T1 CRC.

This study seeks to improve the prediction of recurrence-free survival in individuals who have survived T1 CRC.

详细描述

The incidence of invasive submucosal colorectal cancer (T1 CRC) is increasing, likely as a reflection of improved screening and endoscopy use. Current treatment options for T1 CRC focus on less invasive methods (i.e., endoscopic submucosal dissection), and treatment decisions are based on the risk of lymph node metastasis (LNM). Up to 70-80% of T1 CRC patients may undergo surgery, with adjuvant chemotherapy recommended only for those with LNM.

However, current clinical practice guidelines are considered to be overly aggressive and recommend the administration of aggressive treatment to many patients who may be cured with non-invasive therapy alone. This results in the overtreatment of many patients, especially those that are currently defined as 'high-risk' T1 CRC. Existing surveillance methods may not adequately predict the prognosis of T1 CRC, lacking established biomarkers for assessing disease-free survival.

This study seeks to validate tissue-based biomarkers (micro-RNA and messenger RNA) that are associated with tumor recurrence after curative resection. The identification of patients at high risk of recurrence may help in the selection of patients who truly benefit from additional oncologic surgery or adjuvant therapy. Previous research by this group has identified miRNA signatures for detecting postoperative tumor recurrence and metastasis in CRC, highlighting their potential as biomarkers for disease progression.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Stage I, pT1 colorectal cancer (TNM classification, 8th edition).
  • Received standard diagnostic, staging, and stage-specific curative-intent resection (endoscopic or surgical, as per local guidelines).
  • Confirmed cancer-free survivorship at the time of study inclusion.

排除标准

  • Lack of informed consent.
  • Induction of neoadjuvant systemic therapy before colorectal cancer resection.
  • Synchronous colorectal and non-colorectal cancer diagnosed at or before surgery.

结局指标

主要结局

Recurrence-free Survival

时间窗: Up to 60 months

Time from curative-intent resection to the development of recurrence (or death)

次要结局

未报告次要终点

研究者

发起方
City of Hope Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (3)

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