| CTRI Number |
CTRI/2021/09/036270 [Registered on: 06/09/2021] Trial Registered Prospectively |
| Last Modified On: |
02/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of detection of Pulmonary TB by computer aided technology |
|
Scientific Title of Study
|
A Pilot Study on feasibility of improving TB Detection using an AI software for CXR screening along with GeneXpert |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asha Thomas |
| Designation |
Head, Radiology Department |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Radiology Department, Bangalore Baptist Hospital
Bellary road, hebbal, Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
8762013211 |
| Fax |
|
| Email |
asha68naveen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asha Thomas |
| Designation |
Head, Radiology Department |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Radiology Department, Bangalore Baptist Hospital
Bellary road, hebbal, Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
8762013211 |
| Fax |
|
| Email |
asha68naveen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asha Thomas |
| Designation |
Head, Radiology Department |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Radiology Department, Bangalore Baptist Hospital
Bellary road, hebbal, Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
8762013211 |
| Fax |
|
| Email |
asha68naveen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cephied,
DLF Towers Shivaji Marg, DSM 214-215, 2 floor, Shivaji Marg, New Delhi, Delhi 110015 |
|
|
Primary Sponsor
|
| Name |
Cepheid |
| Address |
DLF Towers Shivaji Marg, DSM 214-215, 2 floor, Shivaji Marg, New Delhi, Delhi 110015 |
| Type of Sponsor |
Other [Automated molecular diagnostics] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Qure AI |
Level 6, Oberoi Commerz II International Business Park Oberoi Garden City, Yashodham, Goregaon, Mumbai, Maharashtra 400063 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Asha Thomas |
Bangalore Baptist hospital |
Radiology Department Bangalore Baptist Hospital
bellary road Hebbal
Bangalore
KARNATAKA |
8762013211
asha68naveen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review board, Bangalore Baptist Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Presumptive TB patients identified by the clinician/physician based on with symptoms suggestive of TB or with high risk for TB
Patients getting their X-Rays recorded for non-TB related reasons and incidentally detected by the software as having radiological signs of TB based on their chest X-Ray.
|
|
| ExclusionCriteria |
| Details |
Chest Xrays of patients below 6 years not included in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Sensitivity, Specificity of AI based TB reporting
2.Reduction in time to diagnosis of TB from the chest xray
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Additional TB case notifications
2.Gains in diagnostic yield of GeneXpert test |
6 months |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
10/09/2021 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The project aims to ascertain the benefits of using AI for CXR screening for TB prior to confirmatory testing using GeneXpert. Qure’s product, qXR is an AI based Chest X-Ray interpretation software clinically relevant abnormal findings in a Chest X-ray, including indications for TB and COVID within a minute. Once an individual is flagged by qXR as TB presumptive, they are advised to proceed for confirmatory testing using GeneXpert. This study will compare the process which is currently in place for diagnosis of TB at our institution (which includes Genexpert and Chest Xray) with a new process which will include use of the Qure AI. Through this process, we intend to evaluate the software as well as the gains resulting from qXR as a screening tool for TB. |