| 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
|
|
|
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. |