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CTRI Number  CTRI/2024/02/062294 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 24/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to use Artificial Intelligence to predict the outcomes of advanced stage Hodgkin Lymphoma  
Scientific Title of Study   A novel Artificial Intelligence based prognostic approach using PET-CT images and pathology images, for advanced stage Hodgkin Lymphoma. 
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 HASMUKH JAIN  
Designation  Professor Adult Hematolymphoid Unit, Department of Medical Oncology 
Affiliation  Tata Memorial Hospital 
Address  Room No.81, Adult Hematolymphoid Unit Main Building, Ground floor, Tata Memorial Hospital, Dr E. Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA 400012 India
Room No.81, Adult Hematolymphoid Unit Main Building, Ground floor, Tata Memorial Hospital, Dr E. Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India 
Phone  02224177018  
Fax    
Email  dr.hkjain@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR HASMUKH JAIN  
Designation  Professor Adult Hematolymphoid Unit, Department of Medical Oncology 
Affiliation  Tata Memorial Hospital 
Address  Room No.81, Adult Hematolymphoid Unit Main Building, Ground floor, Tata Memorial Hospital, Dr E. Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA 400012 India
Room No.81, Adult Hematolymphoid Unit Main Building, Ground floor, Tata Memorial Hospital, Dr E. Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India 
Phone  02224177018  
Fax    
Email  dr.hkjain@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR HASMUKH JAIN  
Designation  Professor Adult Hematolymphoid Unit, Department of Medical Oncology 
Affiliation  Tata Memorial Hospital 
Address  Room No.81, Adult Hematolymphoid Unit Main Building, Ground floor, Tata Memorial Hospital, Dr E. Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA 400012 India
Room No.81, Adult Hematolymphoid Unit Main Building, Ground floor, Tata Memorial Hospital, Dr E. Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India 
Phone  02224177018  
Fax    
Email  dr.hkjain@gmail.com  
 
Source of Monetary or Material Support  
IIT Bombay - Koita Centre for Digital Health (KCDH), G-22 Ground Floor, KReSIT Building, Main Gate Rd, IIT Area, Powai, Mumbai, Maharashtra 400076 
 
Primary Sponsor  
Name  KOITA CENTRE FOR DIGITAL HEALTH(KCDH) 
Address  KReSIT Building, Powai, Mumbai, Maharashtra 400076 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hasmukh Jain  Tata Memorial Centre  Department of Adult Hematolymphoid Unit, Medical Oncology, Room No 81, Ground Floor, Main Building, Tata Memorial Hospital, Dr. E. Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 02224177018

dr.hkjain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C819||Hodgkin lymphoma, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil   Nil  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with advanced stage Hodgkins Lymphoma.
2. Patients whose baseline PET-CT reports are available.
3. Patients whose baseline paraffin block is available at TMH.
4. Age should be more than equal to 15 years.
 
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Baseline FDG PET-CT results will be used to measure the standardized uptake value of the tumour sites to assess the staging and severity of the disease. At the end of the first stage (Retrospective part), the AI system will learn about the tumour
and will provide a score in a standardized form such as Deauville PET Criteria for its corresponding PET-CT scan #2. The predicted score and actual score from the retrospective study will be correlated. 		 Retrospective Data analysis of PET CT done at the time of diagnosis. 
 
Secondary Outcome  
Outcome  TimePoints 
1. correlation of the prognostic model with respect to 2-year Event Free Survival and overall survival.
2. comparing prognostic value of AI models against available gold standard IPS scores.

 		 2years 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   10/02/2024 
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="2"
Months="0"
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  

The aim of this study is to develop an artificial intelligence algorithm based prognostic model for advanced stage Hodgkin Lymphoma. The study is for patient aged 15 and above and whose PET CT scan reports and paraffin blocks are available at TMH. The treatment of advanced stage Hodgkin’s Lymphoma is often associated with the risk of significant toxicities. The response to the treatment is either known after two cycles of chemotherapy or at the end of the treatment. Since the response is not known until two cycles, the patients are often undertreated or over treated. So, we need better predictive tools at baseline to avoid unnecessary complications.
“Artificial intelligence” in simple terms means the ability of computers to learn and solve problems. Hence in this study we aim to develop the artificial intelligence system from the data obtained from the PET CT and radiology images. This AI model would help in assisting the doctors in choosing the treatment regime for patients with advanced stage HL.
 

 
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