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临床试验/CTRI/2025/10/095713
CTRI/2025/10/095713招募中不适用

IDH1 Biliary Tract Cancer (BTC) Registry

Vedanta Medical Research Foundation1 个研究点 分布在 1 个国家目标入组 200,000 人开始时间: 2025年10月31日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200,000
试验地点
1
主要终点
To describe the profile and patterns of Biliary Tract cancer in patients availing of care at the reporting hospital.

研究概览

简要总结

Biliary tract cancers (BTCs) are a heterogeneous group of highly aggressive, lethal malignancies that are characterized by genomic differences among tumors from different anatomic sites. It is often diagnosed at an advanced stage, and even when resectable at an earlier stage, its high recurrence rate leads to a poor prognosis. India has a high burden of biliary tract tumors, particularly gall bladder cancer (GBC), the incidence is 10 times higher in northern India compared to the southern Indian states and with a significant geographic variance. In India, the young population is affected more in the fifth and sixth decades of life. The deadly nature of BTC, with high mortality rates, is alarmingly high, with only 20% of patients surviving beyond 5 years after diagnosis, posing a significant challenge to the healthcare community.

The increasing number of BTC cases is linked to several risk factors, so understanding the epidemiological factors and molecular characterization of BTCs provides potentially actionable clinical information, which may help in clinical development of therapies targeting actionable alterations with the overall ultimate goal of improving clinical outcomes. The objective of the study is to understand the epidemiological patterns, clinical characteristics, treatment outcomes and molecular characteristics in biliary tract cancers.

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

  • The study will include histopathologically confirmed metastatic Biliary tract cancer patients, who were undergoing treatment or at follow-up visit to the hospital during the study period.
  • All adult patients who are aged 18 and above with biliary tract cancer and are willing to participate in the study.

排除标准

  • Patients who are below 18 years and are not willing to participate.

结局指标

主要结局

To describe the profile and patterns of Biliary Tract cancer in patients availing of care at the reporting hospital.

时间窗: This is an observational study without any intervention. Data will be assessed for all registered patients during two time periods: | 1)Retrospective phase: March 2018 to September 2025 | 2)Prospective phase: October 2025 to June 2027

次要结局

  • Screen eligible patients & abstract medical records to describe the diagnostic, staging, & treatment details of Biliary Tract cancer patients.(24 Weeks)

研究者

发起方
Vedanta Medical Research Foundation
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Bhawna Sirohi

Vedanta Medical Research Foundation (BALCO Medical Centre)

研究点 (1)

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