| 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
|
|
|
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
|
|
|
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 |