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CTRI Number  CTRI/2026/03/105154 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 15/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Other 
Public Title of Study   Low-dose CT based lung cancer screening among high-risk individuals 
Scientific Title of Study   Evaluating the effectiveness of low-dose CT based lung cancer screening among high-risk individuals and availability and impact of lung cancer care pathways 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek Shankar 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 143-A, First Floor, Department of Radiation Oncology
Dr BR Ambedkar Institute Rotary Cancer Hospital All India Institute of Medical Sciences New Delhi
South
DELHI
110029
India 
Phone  9968721213  
Fax    
Email  doc.abhishankar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek Shankar 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 143-A, First Floor, Department of Radiation Oncology
Dr BR Ambedkar Institute Rotary Cancer Hospital All India Institute of Medical Sciences New Delhi
South
DELHI
110029
India 
Phone  9968721213  
Fax    
Email  doc.abhishankar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhishek Shankar 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 143-A, First Floor, Department of Radiation Oncology
Dr BR Ambedkar Institute Rotary Cancer Hospital All India Institute of Medical Sciences New Delhi
South
DELHI
110029
India 
Phone  9968721213  
Fax    
Email  doc.abhishankar@gmail.com  
 
Source of Monetary or Material Support  
Research grant by Bristol Myers Squibb Foundation 
 
Primary Sponsor  
Name  Bristol Myers Squibb Foundation 
Address  Bristol Myers Squibb Corporate Headquarters Route 206 & Province Line Road Princeton, New Jersey 08543, USA 
Type of Sponsor  Other [Foundation] 
 
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 Abhishek Shankar  Room No. 59, Ground Floor, Dr BR Ambedkar Institute Rotary Cancer Hopsital  ALl India Institute of Medical Sciences, Ansari Nagar
South
DELHI 
9968721213

doc.abhishankar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Lung cancer screening with LDCT in individuals with a history of smoking at least 20 pack-years, either current smokers or those who quit within the last 15 years  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low Dose CT Scan  Low dose CT Scan Chest 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  a) 50 to 80 years
b) Male and Female
c) Individuals with a history of smoking at least 20 pack-years, either current smokers or those who quit within the last 15 years
 
 
ExclusionCriteria 
Details  a) Never-smokers, defined as those who smoked fewer than 100 cigarettes in their lifetime
b) Individuals currently receiving treatment for active cancer
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Screen positive rate for LDCT in the early detection of lung cancer in a high-risk Indian population  0, 12, 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Presence & impact of care pathways for patients screened for lung cancer  12 months 
 
Target Sample Size   Total Sample Size="1716"
Sample Size from India="1716" 
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)   01/04/2026 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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 GLOBOCAN 2022 report for India, suggests lung cancer as the second most frequent cancer in males, with a case count at 58,970 forming 8.5% of the entire cancer burden for males in India. Upon including females, lung cancer still figures in the top five (ranked 4th) most frequent cancers in the country with 81,748 cases which is 5.8% of the entire case load of cancer in India. LDCT is the only test to screen for lung cancer recommended by various associations including USPSTF for the high-risk smokers in 50-80 years. There is no conclusive data on the efficacy of LDCT in screening lung cancer in the Indian population and the care pathways which might exist for individuals so diagnosed. There is a severe lack of evidence in accounting for the utility of LDCT in screening lung cancer in India, which is largely formed by underpowered retrospective results. This study will employ a prospective, cohort design in order to evaluate the efficacy of LDCT screening for lung cancer in a high-risk Indian population. The subject will receive a relevant and prompt Multidisciplinary team (MDT) referral if any LDCT scan is found to raise suspicions for cancer. The effective management of lung cancer relies heavily on timely diagnosis, streamlined care pathways and coordinated multidisciplinary treatment approaches. This project also aims to systematically evaluate the existence or absence of formalized care pathways for lung cancer patients within the Indian healthcare system, as part of a broader initiative assessing LDCT screening utility. The project will explore the current referral systems, diagnostic workflows, multidisciplinary team involvement, treatment initiation processes, and follow-up mechanisms. By mapping these pathways, the study will identify key bottlenecks, gaps, and regional disparities affecting patient journeys from suspicion or diagnosis through treatment and survivorship


 
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