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临床试验/CTRI/2025/09/094097
CTRI/2025/09/094097尚未招募不适用

Development and validation of a prognostic model to predict survival in head and neck cancer patients with extranodal extension

RAJIV GANDHI CANCER HOSPITAL AND RESEARCH CENTRE2 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2025年9月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
440
试验地点
2
主要终点
To identify a ‘ high -risk’ cohort within the patients with extranodal extension by designing a nomogram , specifically to identify candidates who might potentially benefit from treatment escalation.

研究概览

简要总结

This is a multicentric retrospective study being conducted at All India Institute of Medical Sciences  New Delhi and Rajiv Gandhi Cancer Institute & Research Centre  New Delhi. The study aims to develop and validate a prognostic model to predict survival outcomes in patients with head and neck squamous cell carcinoma who have pathological Extranodal extension.

Despite receiving standard adjuvant chemoradiotherapy, patients with extranodal extension continue to have poor prognosis with high rates of recurrence. It is unclear whether additional pathological factors such as number of positive nodes, extent of extra nodal extension, tumor subsite, higher T stage, depth of invasion, and margin status independently influence outcomes and necessitate treatment escalation.

In this study, clinicopathological data of patients with extra nodal extension will be collected from both centres. A Cox proportional hazards model will be used to construct and validate a multivariable prognostic model, with internal validation through repeated random split-sample cross-validation and bootstrapping. The expected outcome is the development of a clinically applicable nomogram to identify a high-risk subset of patients with ENE who may be candidates for future trials on treatment intensification.

The findings are anticipated to provide an evidence-based tool for risk stratification and treatment decision-making in head and neck cancer patients with extra nodal extension.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • All head and neck cancer cases of the oral cavity , oropharynx , larynx and hypopharynx with histologically confirmed extra nodal extension from two centres as mentioned earlier.

排除标准

  • Patients with recurrent disease at presentation, distant metastases at diagnosis, or incomplete follow-up data.

结局指标

主要结局

To identify a ‘ high -risk’ cohort within the patients with extranodal extension by designing a nomogram , specifically to identify candidates who might potentially benefit from treatment escalation.

时间窗: 31 months

次要结局

未报告次要终点

研究者

发起方
RAJIV GANDHI CANCER HOSPITAL AND RESEARCH CENTRE
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Mudit Agarwal

Rajiv Gandhi Cancer Institute and Research Centre

研究点 (2)

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