| 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
|
|
|
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
|
|
|
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. |