跳至主要内容
临床试验/CTRI/2025/12/099382
CTRI/2025/12/099382尚未招募不适用

To study the quality of life in Head and Neck Squamous cell carcinoma patients undergoing neck node dissection, with secondary analysis of diagnostic accuracy and reliability of USG based Node-RADS in clinically N0 neck.

ICMR1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2025年12月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
ICMR
入组人数
97
试验地点
1

研究概览

简要总结

HNSCC represents a significant proportion of cancer burden in India, accounting for approximately 40% of all malignancies. Neck dissection remains a vital component of curative treatment but is often associated with long-term morbidity affecting overall QoL. Despite its widespread use, there is limited prospective data in the Indian population regarding post-operative QoL outcomes and their predictors. Additionally, while Node-RADS is a novel radiological scoring system for lymph node assessment, its diagnostic accuracy and clinical reliability, especially in clinically N0 necks, have not been thoroughly validated. This study will be the first study to address these crucial gaps by evaluating both functional QoL outcomes and the diagnostic performance of imaging tools like Node-RADS and USG-guided FNAC. As the first prospective study of its kind in the Indian context, it has the potential to standardize neck node evaluation protocols and enhance individualized care, ultimately improving long-term outcomes and resource utilization in oncology practice

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

  • Scheduled to receive neck dissection (along with surgical treatment of primary tumor) Not received any neo-adjuvant treatment chemotherapy or radiotherapy.

排除标准

  • Recurrent disease Previous neck trauma, neck surgery, radiation to the neck Neurological illness, congenital malformations of the neck Cognitive impairment or inability to complete questionnaires Known shoulder pathology.

研究者

发起方
ICMR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Avni Agrawal

Kasturba Medical College , Manipal (MAHE)

研究点 (1)

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