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临床试验/CTRI/2025/09/094632
CTRI/2025/09/094632尚未招募不适用

The impact of primary tumour location and molecular profile on recurrence patterns following liver resection for colorectal liver metastases (CRLM): a multicentre cohort study (BIO-CRLM Study)

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2025年10月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
5,000
试验地点
1
主要终点
impact of primary tumour location and tumour molecular profile on patterns of recurrence and survival following curative-intent liver resection for CRLM

研究概览

简要总结

Large bowel cancer that has spread to liver called as Colorectal liver metastases (CRLMs) do well with liver sugery (resection). Liver surgery helps these patients live longer, sometimes up to 5 years or more, but unfortunately, the cancer often comes back, in half of these patients, usually within 2 years of surgery. Present study analyses the molecular characteristics and anatomical location of primary tumor in large bowel (right vs left vs rectum). Early findings show that bowel cancers from the right side may behave more aggressively, especially when they carry certain mutations like BRAF. These patients tend to have widespread cancer after surgery. On the other hand, people with left-sided cancers that lack these mutations may have slower-growing disease and better chances of avoiding recurrence.

To explore this further, researchers are reviewing data from many hospitals to see how tumour location and genetics together impact cancer comeback and survival. The goal is to help doctors better predict risk and choose the best treatment plan for each patient—including who will benefit most from surgery or chemotherapy.

In this study, the coordinating centre will only analyse anonymized data shared by the participating centres. No additional tests or interventions will be performed on patients. Strict confidentiality measures will be in place, ensuring that personal information remains protected and is only accessible to the research team.

The collected data will be securely transferred to the coordinating center through a secure electronic system known as REDCap, where it will be analyzed and used to generate results for publication, contributing to improved surgical strategies for colorectal cancer with liver metastases.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged 18 years and above at the time of liver surgery with histologically confirmed colorectal adenocarcinoma and liver metastases.
  • Patients who underwent curative-intent liver resection from January 2017 to October
  • 3.Known molecular profile for at least 1 of the following: KRAS/NRAS, BRAF or MSI.
  • Ideally, KRAS/NRAS and BRAF status will be known for all patients after 2010.

排除标准

  • Incomplete macroscopic (R2) resection 2.Concomitant unresectable extrahepatic disease 3.Patients who have undergone treatment for extrahepatic disease (e.g. lung ablation or resection)
  • Insufficient data for key variables (unknown primary, lack of follow up data) 5.Non-adenocarcinoma histology.

结局指标

主要结局

impact of primary tumour location and tumour molecular profile on patterns of recurrence and survival following curative-intent liver resection for CRLM

时间窗: upto 18 months after surgery date

次要结局

  • predictors of isolated liver-only recurrence vs. lung-only recurrence versus disseminated disease(upto 18 months after surgery date)
  • use of systemic therapy (downstaging or post-resection palliative) varies between patients with different primary tumour sites, and whether the benefit of chemotherapy differs by molecular subtype(upto 18 months after surgery date)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shraddha Patkar

Tata Memorial Hospital

研究点 (1)

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