跳至主要内容
临床试验/CTRI/2026/01/100209
CTRI/2026/01/100209招募中不适用

Improving histopathological evaluation of Oral Squamous Cell Carcinoma with and without lymph node metastasis through AI driven algorithm using Foxp3 and CD43 expression

未提供2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年1月12日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
2
主要终点
Biomarker expression in OSCC tissues with metastatic lymph nodes present/absent (comparison of primary tissue expression in two groups as well as primary tissues with that of nodes)

研究概览

简要总结

Our study aims to investigate the role of immune suppression in OSCC progression and metastasis by evaluating CD43 & Fox P3 expression, and to develop an AI-based system for automated detection and spatial mapping of Foxp3 + cells in histopathologic H&E stained slides for enhanced diagnostic insight. In PHASE 1 of the study we will do Immuno-histochemical analysis to quantify and compare CD43 & Foxp3 expression in primary tumor tissues as well as metastatic lymph nodes of both metastatic and non-metastatic OSCC cases. On the basis of calculated expression of  Foxp3/CD43 ratio we will assess its correlation with metastatic status and clinicopathologic parameters.In PHASE 2 of the study we will do AI based detection & overlay by developing and validating a deep learning algorithm that detects Foxp3+ cells by training on annotated IHC slides, aligns IHC & H&E images through spatial alignment, and generates interpretable overlays and heat maps of Foxp3+ cell distribution on H&E stained tissue. Finally we will validate the AI model’s performance against manual pathologist annotation using standard metrics.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Diagnosed with Oral Squamous Cell Carcinoma.

排除标准

  • all patients with any other diagnosed pathologies than oral squamous cell carcinoma, Patients diagnosed with oral squamous cell carcinoma with no status of lymph node metastasis.

结局指标

主要结局

Biomarker expression in OSCC tissues with metastatic lymph nodes present/absent (comparison of primary tissue expression in two groups as well as primary tissues with that of nodes)

时间窗: 4 weeks

次要结局

  • AI-based prediction of biomarker expression for cases without lymph node metastasis that with those that show metastasis in lymph nodes(8 weeks)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Sakshi Janbade

Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital

研究点 (2)

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