| CTRI Number |
CTRI/2025/12/098846 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The role of Artificial Intelligence in Cancer Management |
|
Scientific Title of Study
|
Evaluating the concordance between AI-based Large Language Model recommendations and Virtual Molecular Tumor Board expert consensus for solid tumor cases in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Arun Seshachalam |
| Designation |
Medical and Paediatric Oncologist |
| Affiliation |
Dr GVN Cancer Institute GVN Riverside Hospital Tiruchirappalli Tamil Nadu |
| Address |
Dr GVN Cancer Institute
GVN Riverside Hospital
Trichy Chennai NH 45
Thimmarayasamuthiram
Thiruvanaikoil Tiruchirappalli
Tamil Nadu
Tiruchirappalli
TAMIL NADU
620005
India |
| Phone |
9786220191 |
| Fax |
|
| Email |
dr.arunseshachalamtalks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Arun Seshachalam |
| Designation |
Medical and Paediatric Oncologist |
| Affiliation |
Dr GVN Cancer Institute GVN Riverside Hospital Tiruchirappalli Tamil Nadu |
| Address |
Dr GVN Cancer Institute
GVN Riverside Hospital
Trichy Chennai NH 45
Thimmarayasamuthiram
Thiruvanaikoil Tiruchirappalli
Tamil Nadu
Tiruchirappalli
TAMIL NADU
620005
India |
| Phone |
9786220191 |
| Fax |
|
| Email |
dr.arunseshachalamtalks@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Arun Seshachalam |
| Designation |
Medical and Paediatric Oncologist |
| Affiliation |
Dr GVN Cancer Institute GVN Riverside Hospital Tiruchirappalli Tamil Nadu |
| Address |
Dr GVN Cancer Institute
GVN Riverside Hospital
Trichy Chennai NH 45
Thimmarayasamuthiram
Thiruvanaikoil Tiruchirappalli
Tamil Nadu
Tiruchirappalli
TAMIL NADU
620005
India |
| Phone |
9786220191 |
| Fax |
|
| Email |
dr.arunseshachalamtalks@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. GVN Cancer Institute, GVN Riverside Hospital |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Arun Seshachalam |
GVN Riverside Hospital |
Medical Oncology Department, Dr. GVN Cancer Institute,
GVN Riverside Hospital,
Trichy Chennai NH 45,
Thimmarayasamuthiram,
Thiruvanaikoil, Tiruchirappalli,
Tamil Nadu 620005
Tiruchirappalli
TAMIL NADU |
9786220191
dr.arunseshachalamtalks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GVN RIVERSIDE HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age 18.00 to 80.00 years. The subject should have solid tumors. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Concordance rate between AI and expert vMTB recommendations |
Within 8 weeks after presenting the case in the Virtual Molecular Tumour Board |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/12/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 prospective, blinded, cross-sectional study
evaluates the concordance between treatment recommendations generated by large
language model (LLM)–based decision-support tools and expert consensus from the
Tamil Nadu Medical and Pediatric Oncologist Society (TAMPOS) Virtual Molecular
Tumor Board (vMTB) for precision oncology cases in India. Consecutive
de-identified solid tumor cases discussed at vMTB sessions (September–December
2025) will be analyzed. AI tools will undergo extraction validation, reproducibility
testing (two-run protocol with escalation to a third run if inconsistent), and blinded
concordance scoring across pathway, therapy, and evidence level dimensions. The
primary hypothesis is that LLM systems will meet predefined concordance
thresholds (~90% for high-evidence and ~40% for low-evidence recommendations),
consistent with international benchmarking studies (Sunami et al., 2024). |