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临床试验/CTRI/2025/01/079408
CTRI/2025/01/079408尚未招募2 期

Development of point of care cytology screening tool for Oral potentially malignant disorders and Oral squamous cell carcinoma using Deep learning Convolutional Neural Network

Indian Council of Medical Research (ICMR)1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2025年8月31日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
900
试验地点
1
主要终点
Development of point of care cytology screening tool and deep learning model for screening of OPMDs and OSCC.

研究概览

简要总结

Title of the proposed research project: Development of point of care cytology screening tool for Oral potentially malignant disorders and Oral squamous cell carcinoma using Deep learning Convolutional Neural Network

Screening of oral potentially malignant disorders (OPMDs) such as Leukoplakia and oral squamous cell carcinoma (OSCC) in remote areas often rely on traditional techniques which can be time consuming, costly and inaccessible. There is also a shortage of trained healthcare professionals in these regions, leading to delays in screening and initiation of treatment. These limitations highlight the need for innovative, accessible and accurate screening tool that can be deployed in remote settings for early screening of oral cancer.

Novelty

The novelty lies in the convergence of mobile technology, AI-based screening, and portable microscopy to create a user-friendly screening tool for OPMDs and OSCC in low resourced remote setting. This approach enables real-time analysis of PAP smears directly on a smartphone, facilitating screening accuracy and timely intervention in low resourced areas given the doctor patient ratio is relatively poor.

Objectives

  1. To develop Deep learning convolutional neural network algorithm for screening of papanicoloau (PAP) stained smears of OPMDs and OSCC.

  2. Training of dataset and validation of model

  3. To Develop point of care cytology screening tool for screening of OPMDs and OSCC.

  4. Clinical validation of the screening tool

Methods

  1. Data Collection and Pre-processing

  2. Training and Validation

  3. Deployment and Integration

  4. Clinical Validation

Expected Outcome: Development of point of care cytology screening tool and deep learning model for screening of OPMDs and OSCC.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Study subjects who have given written informed consent Control group without tobacco habit Subjects clinically diagnosed with OPMDS and OSCC.

排除标准

  • Subjects who had undergone treatment for malignancy Subjects with recurrence of OSCC Subjects with co-existing malignancy Immune-compromised subjects and those suffering from chronic debilitating diseases such as diabetes, tuberculosis.

结局指标

主要结局

Development of point of care cytology screening tool and deep learning model for screening of OPMDs and OSCC.

时间窗: Baseline

次要结局

  • Validation of the tool gaining acceptance among healthcare providers in remote setting areas.(Baseline)

研究者

发起方
Indian Council of Medical Research (ICMR)
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

DrPreethi Sharma

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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