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CTRI Number  CTRI/2024/11/076681 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 07/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   A study to see the Genomic Signatures from lung tissue images using OncoPredikt an AI Platform in Lung Adenocarcinoma Patients.  
Scientific Title of Study   A prospective, interventional, single center study to correlate outcomes using OncoPredikt, an (AI-enabled platform) to predict genomic signatures from histopathological images in lung adenocarcinoma patients.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nirmal Raut  
Designation  Consultant Medical Oncologist 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPD No. 3, 1st Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Thane, Maharashtra 401107

Thane
MAHARASHTRA
401107
India 
Phone  9930398156  
Fax    
Email  pinirmal123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nirmal Raut  
Designation  Consultant Medical Oncologist 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPD No. 3, 1st Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Thane, Maharashtra 401107

Thane
MAHARASHTRA
401107
India 
Phone  9930398156  
Fax    
Email  pinirmal123@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nirmal Raut  
Designation  Consultant Medical Oncologist 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPD No. 3, 1st Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Thane, Maharashtra 401107

Thane
MAHARASHTRA
401107
India 
Phone  9930398156  
Fax    
Email  pinirmal123@gmail.com  
 
Source of Monetary or Material Support  
OneCell Diagnostic India Pvt. Ltd. 209, B Wing, Go Square, Aundh Hinjewadi Road, Wakad, Pune, Maharashtra, India 411057 
 
Primary Sponsor  
Name  OneCell Diagnostic India Pvt. Ltd 
Address  209, B Wing, Go Square, Aundh Hinjewadi Road, Wakad, Pune, Maharashtra, India 411057 
Type of Sponsor  Other [Diagnostic Laboratory] 
 
Details of Secondary Sponsor  
Name  Address 
Bhaktivedanta Hospital and Research Institute  Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Mira Bhayandar, Maharashtra 401107 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nirmal Raut   Bhaktivedanta Hospital and Research Institute  OPD No. 03, 1st Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Mira Bhayandar, Maharashtra 401107
Thane
MAHARASHTRA 
9930398156

pinirmal123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committe For Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C34||Malignant neoplasm of bronchus andlung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AI based platform- OncoPredikt  The AI-based platform, OncoPredikt, predicts molecular and gene mutation status from H&E-stained digital slides and correlates these findings with outcomes from conventional testing methods. This procedure is performed only once, specifically at the point of initial biopsy sample collection for cancer confirmation. The OncoPredikt AI model delivers results in under 15 minutes 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details 
1. Patients whose NGS (conventional testing) reports are available with confirmed diagnosis of Lung cancer with or without mutation status in the listed genes. (KRAS, BRAF, EGFR, RET, ALK, ROS1, MET, STK11, ERBB2, NTRK mutations).
2. Patients whose Lung biopsy H&E slides or tissue biopsy slide is available.
3. Patients who would be willing to participate voluntarily.
 
 
ExclusionCriteria 
Details  Patients who do not have lung adenocarcinoma with a biomarker. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
OncoPredikt-based prediction of lung panel gene signature mutation status can be accurately performed on diagnostic H&E slides potentially yielding results quickly and affordably, even when limited tissue is available for testing, thus, providing a reliable and accurate screening tool to predict lung panel gene mutations.



 
15 days

 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study focuses on the application of the OncoPredikt AI platform for predicting and correlating genomic signatures in lung cancer from histopathological lung biopsy slides. Lung cancer, the most commonly reported cancer worldwide, accounted for approximately 2.2 million new cases and 1.8 million deaths in 2020. Molecular classification of lung cancer, particularly the detection of specific mutations in genes like EGFR, BRAF, KRAS, and others, has advanced targeted therapeutic strategies. The study design is a prospective, interventional, single-center approach with a sample size of 52 cases and having study duration for patient recruitement is  12 months. It includes patients with confirmed lung cancer diagnoses and available Next-Generation Sequencing (NGS) reports, specifically for those with or without mutations in a set of key genes. The exclusion criterion focuses on patients without lung adenocarcinoma with a biomarker. The study will record various data parameters, including demographic details, cancer stage at diagnosis, mutation status, treatment details (chemotherapy, surgery, targeted therapy, radiotherapy, and immunotherapy), and the interpretation from the OncoPredikt AI model. The primary objective is to evaluate the accuracy of OncoPredikt in predicting lung panel gene signature mutations using diagnostic H&E slides, potentially offering a quicker and more cost-effective screening tool, even when tissue availability is limited. 

 
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