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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  
AIIMS, New Delhi 
 
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  
Name  Address 
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 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  
Status 
Not Applicable 
 
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

 
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