| CTRI Number |
CTRI/2021/03/031926 [Registered on: 11/03/2021] Trial Registered Prospectively |
| Last Modified On: |
10/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of artificial intelligence based scoring of hormone expression in breast cancer on treatment decision making. |
|
Scientific Title of Study
|
Validation of artificial intelligence (AI) based pathology solution in scoring of biomarker expression in breast cancer and its impact on clinical decision making in breast cancer therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Brij Mohan Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pathology
Kasturba Medical COllege, Manipal
Basic Sciences Building
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9663984859 |
| Fax |
|
| Email |
brij.singh@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brij Mohan Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pathology
Kasturba Medical COllege, Manipal
Basic Sciences Building
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9663984859 |
| Fax |
|
| Email |
brij.singh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brij Mohan Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pathology
Kasturba Medical COllege, Manipal
Basic Sciences Building
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9663984859 |
| Fax |
|
| Email |
brij.singh@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Applied Materials India PVT LTD.
International technology park,
Whitefield road,
Bangalore-560066
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Applied Materials India PVT LTD |
| Address |
International Technology Park
Whitefield Road
Bangalore
Pin code 560066
Karnataka
India |
| Type of Sponsor |
Other [Software solutions for diagnosis & prognosis of diseases] |
|
|
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 Brij Mohan Kumar Singh |
Kasturba Hospital |
Department of Pathology
Kasturba Medical College, Manipal
Basic Sciences Building
Manipal
Pincode 576104
Udupi
KARNATAKA |
9663984859
brij.singh@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Female patients, post-surgery with diagnosed breast carcinoma subjected to immunohistochemical analysis of hormone receptors(ER, PR, Her2-neu and Ki67) on the breast specimen. |
|
| ExclusionCriteria |
| Details |
Cases were consent could not be obtained |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Utility and effectiveness of computer assisted artificial intelligence (AI) based analysis to objectively quantify the biomarker expression in breast cancer. |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impact of AI based scoring in deciding therapy modulation in patient diagnosed with breast cancer. |
4 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
15/03/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective cross-sectional study that will be conducted on cases of breast carcinoma. Glass slides prepared from blocks containing tumour tissue would be stained by immunohistochemistry for ER, PR, and HER2/neu expressions and Ki 67. The IHC slides of ER, PR, HER2 neu and Ki 67 will be de-identified and coded. 4 pathologists will independently score ER, PR, Her 2/neu and Ki 67 expression. The results of manual scoring will be compared with that of artificial intelligence (AI) based scoring. The scores of IHC expression of ER, PR, Her 2 and ki67 obtained manually from pathologists and AI-based algorithm will be provided to the blinded medical oncologist who will decide and chart out the treatment plan separately for both manual score and the AI-based score based on these biomarkers expression scores. The treatment plan for both arms will be compared to study the impact of the AI-based solutions on clinical decision making and planning of further treatment for a patient with breast cancer. |