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CTRI Number  CTRI/2024/02/062417 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On: 28/03/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   2PCubeHealth project for early detection of Cancer 
Scientific Title of Study   2PCubeHealth- Artificial Intelligence Powered Diagnostic Tools for Early Detection of Cancer 
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 Jitendra Kumar Singh 
Designation  Director and Senior Oncologist 
Affiliation  S S Hospital and Research Centre, Patna (INDIA) 
Address  Room No. 101, Dept of Clinical Oncology, SSHRC, Kankarbagh, Patna
Dr. J.K. Research Group in collaboration with Dr. Krishna Dev Kumar (Director, iSAC Systems)
Patna
BIHAR
800020
India 
Phone  9431021001  
Fax    
Email  drjksingh.onco@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishna Dev Kumar 
Designation  Visiting Scientist (Director iSAC systems) 
Affiliation  S. S. Hospital and Research Centre, Patna 
Address  Room No. 102, Dept of Clinical Oncology, SSHRC, Kankarbagh, Patna

Patna
BIHAR
800020
India 
Phone  7677797741  
Fax    
Email  kkumar@isacsystems.com  
 
Details of Contact Person
Public Query
 
Name  Mr Sachidananda Behera 
Designation  Visiting Researcher (Scientist-B) 
Affiliation  S. S. Hospital and Research Centre, Patna 
Address  Room No. 103, Dept of Clinical Oncology, SSHRC, Kankarbagh, Patna

Patna
BIHAR
800006
India 
Phone  7903475652  
Fax    
Email  sachidananda.niper@gmail.com  
 
Source of Monetary or Material Support  
S. S. Hospital and Research Centre, Patna (INDIA) 
 
Primary Sponsor  
Name  Dr Krishna Dev Kumar 
Address  Visiting Scientist (Director iSAC Systems) & Collaborator, S S Hospital and Research Centre Kankarbagh, Patna 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Mr Prashant Shanker Pathak  Co-Investigator of 2PCHealth Project (Ekagrata Inc, Toronto, Canada)  
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 JK Singh  S S hospital and Research Centre, Patna  Room No. 201, Department of Research, SSHRC, Kankarbagh, Patna
Patna
BIHAR 
9431021001

drjksingh.onco@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S S Hospital and Research Centre, Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  For comparative analysis 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (3) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Diagnosed with Cancer of breast and/or Head and Neck etc
Willing to participate in the studyShould not have HIV/STDs, TB, severe mental disorders
Should not be terminally ill 
 
ExclusionCriteria 
Details  Patients below 10 years age and above 75 years age
Patients who are terminally ill
Unwilling to participate in study
Terminally ill patients
Cancer patients having co-morbid conditions  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The proposed study involves the integration of 2PCube for Health to clinical datasets for early detection of cancer. 2PCube will be adapted and customized for health as a new platform 2PCubeHealth and is based on an optimal integration of physics-based and computational intelligence-based techniques for early detection.  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
Development of validated system for early detection of Cancer  up to 1 year 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   21/02/2024 
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)
Modification(s)  
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  

The proposed study on early cancer detection is grounded in the potential to significantly transform cancer diagnosis and treatment. The development of 2PCube was carried out through several projects completed successfully by Dr. Krishna Dev Kumar, who is an international renowned expert in Artificial Intelligence and Digital Twin-based system fault diagnosis, prognosis and recovery. The 2PCube has successfully predicted early failures (3 to 6 months ahead) of critical systems in aerospace, manufacturing and transportation sectors.  Early cancer detection is critical for early intervention and better patient outcomes. 2PCube solution for health (2PCubeHealth) can analyze vast amounts of medical data with high precision, potentially reducing the rates of false positives and false negatives in cancer screenings. Furthermore, it can process and analyze medical data much faster than humans, enabling rapid diagnosis and reducing the time between detection and treatment initiation. This is particularly important for aggressive cancers. Finally, 2PCubeHealth’s early detection has the potential to reduce the overall financial burden on patients and healthcare systems by preventing late-stage cancer cases that are more costly to treat.

The proposed study will be carried out under the clinical supervision of Dr. J.K. Singh (Senior Oncologist and Padmashri Awardee) at S. S. Hospital and Research Centre, Patna. This observational study will take use of the image-based datasets of diagnosis of Cancer patients who will participate in the project work. 

 
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