| CTRI Number |
CTRI/2024/04/065171 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Artificial Intelligence Approach to Early Detection of Breast and Cervical Cancers in Indian Patients. |
|
Scientific Title of Study
|
To study the potential of a predictive Artificial Intelligence tool to foster early identification of symptoms and criticality in breast and cervical cancers in Indian patients. |
| 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 Sushma Bhatnagar |
| Designation |
Chief, Professor and Head |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Room No. 242, 2nd Floor, Dr. B.R.A. IRCH, All India Institute of Medical Science (AIIMS), Ansari Nagar
South DELHI 110029 India |
| Phone |
9811326453 |
| Fax |
|
| Email |
sushmabhatnagar1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sushma Bhatnagar |
| Designation |
Chief, Professor and Head |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Room No. 242, 2nd Floor, Dr. B.R.A. IRCH, All India Institute of Medical Science (AIIMS), Ansari Nagar
South DELHI 110029 India |
| Phone |
9811326453 |
| Fax |
|
| Email |
sushmabhatnagar1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sushma Bhatnagar |
| Designation |
Chief, Professor and Head |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Room No. 242, 2nd Floor, Dr. B.R.A. IRCH, All India Institute of Medical Science (AIIMS), Ansari Nagar
South DELHI 110029 India |
| Phone |
9811326453 |
| Fax |
|
| Email |
sushmabhatnagar1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Dr. B.R.A. IRCH, All India Institute of Medical Science (AIIMS), Ansari Nagar
South
DELHI
110029
India |
| Type of Sponsor |
Research institution |
|
|
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 Sushma Bhatnagar |
All India institute of Medical science (AIIMS |
Department of Onco-Anaesthesia & Palliative Medicine, Dr.B.R.A. IRCH, AIIMS, Ansari Nagar South DELHI |
9811326453
sushmabhatnagar1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
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, (2) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient with diagnoses of carcinoma breast and carcinoma cervix
2.Willing to give consent for enrollment in the study.
4.Able to understand Hindi or English
5.Able to communicate properly
|
|
| ExclusionCriteria |
| Details |
1. Unable to understand or answer a clinician-administered ESAS symptom questionnaire
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop and pilot an AI tool and its outcome to identify critical burdens of patients with breast and cervical cancers in Indian female patients on first visit and subsequent follow up visits. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate clinician experience with the tool and barriers and facilitators to the implementation of the tool and palliative care intervention. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="2400" Sample Size from India="2400"
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)
|
12/04/2024 |
| 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
|
Artificial intelligence models can help distinguish urgent problems, an especially important goal in overstretched health systems. Timely, effective care of symptoms reduces mortality and improves the quality of life in cancer patients. A predictive model can help predict symptoms and symptomatic criticality earlier in the course of disease. Our overarching objective is to study the potential of a predictive A.I. tool to foster early identification of symptoms and criticality in cervical and breast cancers in Indian female patients. To develop and pilot an AI tool and its outcome to identify critical burdens of patients with breast and cervical cancers the patients with breast and cervical cancers coming to the pain and palliative care OPD/IPD will be enrolled and subsequent follow-up will be done. The enrolment of patients will be done through Google form which consists of Socio-demographic data, WHO well-being questionnaire, ECOG, and ESAS. To ensure best practices for transparency, validation, and reproducibility, we will follow the clinical A.I. modeling checklist and CONSORT-AI standards. Models will be developed through the following reproducible pipeline of 5 steps- 1-Partitioning data, 2-Optimization, 3-Model selection, 4-Performance evaluation, and 5-Model examination. To evaluate clinician experience with the tool and barriers and facilitators to the implementation of the tool and palliative care intervention, the study will be a qualitative study using implementation science methods, which we will pursue by interviewing site clinicians regarding how they might use a mHealth tool and integrate it within their routine workflows. We will identify initial clinical participants at the initial 10 intervention sites by referral from each site’s Principal Investigator. Participants may be multidisciplinary palliative care or oncology team members including physicians and non-physicians with symptom management responsibilities, primarily physicians or nurses. They need to be English (interview by Stanford or AIIMS) or Hindi speakers (interview by AIIMS). Data analysis will follow standard mixed inductive, deductive qualitative methods (e.g., dual coding, development of a primary codebook, secondary coding, iterative thematic development by consensus, goal standard adjudication of disagreement). Atlas.ti Software to be used for data analytics and symptom criticality tool development |