| CTRI Number |
CTRI/2026/01/100209 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Improving histological diagnosis of oral cancer by assessment of lymph node involvement through AI based algorithm using biomarker expression |
|
Scientific Title of Study
|
Improving histopathological evaluation of Oral Squamous Cell Carcinoma with and without lymph node metastasis through AI driven algorithm using Foxp3 and CD43 expression |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Janbade |
| Designation |
MDS Pursuing |
| Affiliation |
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital |
| Address |
Room no. 308, Department of Oral & Maxillofacial Pathology and Oral Microbiology, Panjab University
SECTOR 25, Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
7814455985 |
| Fax |
|
| Email |
sakshijanbade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shally Gupta |
| Designation |
MDS Pursuing |
| Affiliation |
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital |
| Address |
Room no.306, Department of Oral & Maxillofacial Pathology and Oral Microbiology, Panjab University
SECTOR 25, Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9914016745 |
| Fax |
|
| Email |
shallygupta@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Janbade |
| Designation |
MDS Pursuing |
| Affiliation |
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital |
| Address |
Room no. 308, Department of Oral & Maxillofacial Pathology and Oral Microbiology, Panjab University
SECTOR 25, Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
7814455985 |
| Fax |
|
| Email |
sakshijanbade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital, Panjab University, Sector 25, Chandigarh |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sakshi Janbade |
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital |
Room no. 308, Department of Oral & Maxillofacial Pathology and Oral Microbiology,Dr HSJIDS, Panjab University, Sector 25 Chandigarh
Chandigarh
CHANDIGARH |
07814455985
sakshijanbade@gmail.com |
| Dr Satnam Jolly |
PGIMER CHD |
Room no. 104, Oral Health Sciences Centre, Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
99142 87909
satnamsurgeon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| PGIMERIEC |
Approved |
| PUIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with Oral Squamous Cell Carcinoma |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AI-based prediction of biomarker expression for cases without lymph node metastasis that with those that show metastasis in lymph nodes |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
12/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
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. |