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临床试验/NCT07306390
NCT07306390尚未招募不适用

Distribution and Analysis of Metastatic Lymph Nodes in Colorectal Cancer Patients (DIAMOND)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,200
试验地点
2
主要终点
The spatial distribution of metastatic lymph nodes

研究概览

简要总结

The goal of this observational study is to learn about the spatial distribution and significance of metastatic lymph nodes in colorectal cancer patients. The main question it aims to answer is:

  • What is the spatial distribution pattern of metastatic lymph nodes in patients with colorectal cancer?
  • Can the spatial distribution pattern of metastatic lymph nodes in patients with colorectal cancer guide clinical practice? Participants should undergo regular follow-up examinations for at least 5 years after the surgery.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 80 years
  • Pathologically confirmed adenocarcinoma of the colon or rectum
  • Underwent radical resection for colorectal cancer with a D3 lymphadenectomy and lymph nodes were submitted for pathological examination according to standardized station-based and distance-based protocol
  • No distant metastasis or distant metastasis within 6 months after surgery
  • No history of other malignant tumors or severe systemic diseases
  • No immune diseases or inflammatory bowel diseases
  • Non-emergency surgery
  • With complete clinicopathological and follow-up data

排除标准

  • Pathologically confirmed benign tumors or non-adenocarcinoma malignancies
  • Underwent local excision or palliative resection
  • Regional lymph nodes were not dissected or submitted for pathological examination according to the unified station-based or distance-based protocol
  • With distant metastasis or distant metastasis within 6 months after surgery
  • Dual or multiple primary colorectal cancers or concurrent other malignant tumors
  • Had a previous diagnosis of immune diseases or inflammatory bowel disease such as ulcerative colitis or Crohn's disease
  • Underwent emergency surgery
  • Had incomplete clinicopathological or follow-up data

结局指标

主要结局

The spatial distribution of metastatic lymph nodes

时间窗: From enrollment to 14 days after surgery (at the completion of postoperative pathological examination)

次要结局

  • Disease-free survival(From date of surgery until the date of first documented local recurrence, distant metastasis, or date of death from any cause, whichever came first, assessed up to 60 months)
  • Overall survival(From date of surgery until the date of death from any cause, whichever came first, assessed up to 60 months)

研究者

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

HAI ZENG ZHAGN

Medical Doctor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (2)

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