Lung CancerILSTNCT07590440
Indian Lung Screening Trial
A study testing Low dose CT in people with Lung Cancer, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Low dose CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,716 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with a history of smoking at least 20 pack-years
- either current smokers or those who quit within the last 15 years
Who cannot join
- Person who smoked fewer than 100 cigarettes in their lifetime
- individuals currently receiving treatment for active cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Dr Bhimrao Ambedkar Institute Rotary Cancer Hospital, AIIMS, New Delhi, India
Delhi, National Capital Territory of Delhi, 110029
Abhishek Shankar, MD, +919968721213, doc.abhishankar@gmail.com
Abhishek Shankar, MD
About this study
Official title: Evaluating the Effectiveness of Low-dose CT Based Lung Cancer Screening Among High-risk Individuals and Availability and Impact of Lung Cancer Care Pathways
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.
- Conditions
- Lung Cancer
- Being tested
- Low dose CT
- Keywords
- Lung Cancer, Screening, Early detection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose CTOther
Participants will undergo comprehensive baseline lung health assessments including clinical examination and questionnaire administration, followed by an LDCT scan. Participants with positive LDCT findings will be referred immediately to a multidisciplinary team (MDT) for further management.
If the baseline LDCT is indeterminate, the participant will undergo a Nodule Follow-Up CT (NFU CT). A positive NFU CT will prompt MDT referral. In cases where the NFU CT remains indeterminate, a second NFU CT will be performed. A positive result at this stage will also result in MDT referral, while a negative result will lead to re-assessment during the next scheduled screening round.
| Study group | Role | What they receive |
|---|---|---|
| LDCT | Other | Low Dose CT Scan for lung cancer screening Receives: Other: Low dose CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screen Positive Rate
Screen positive rate of LDCT based lung cancer screening in a high-risk Indian population
Measured: 0, 12, 24 months
Screen positive rate for LDCT in the early detection of lung cancer in a high-risk Indian population
Measured: 0, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,716 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhishek Shankar, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590440
- Sponsor's protocol ID
- AIIMSA5189/07.11.2025
- Acronym
- ILST
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Low-dose CT Based Lung Cancer Screening Among High-risk Individuals and Availability and Impact of Lung Cancer Care Pathways
- ClinicalTrials.gov ID
- NCT07590440
- Acronym / sponsor ID
- ILST / AIIMSA5189/07.11.2025
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Screening, Early detection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,716 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDCT | Other | Other: Low dose CTLow Dose CT Scan for lung cancer screening |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals with a history of smoking at least 20 pack-years
- either current smokers or those who quit within the last 15 years
Key exclusion criteria (2 listed)
- Person who smoked fewer than 100 cigarettes in their lifetime
- individuals currently receiving treatment for active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose CTParticipants will undergo comprehensive baseline lung health assessments including clinical examination and questionnaire administration, followed by an LDCT scan. Participants with positive LDCT findings will be referred immediately to a multidisciplinary team (MDT) for further management. If the baseline LDCT is indeterminate, the participant will undergo a Nodule Follow-Up CT (NFU CT). A positive NFU CT will prompt MDT referral. In cases where the NFU CT remains indeterminate, a second NFU CT will be performed. A positive result at this stage will also result in MDT referral, while a negative result will lead to re-assessment during the next scheduled screening round. | Other | LDCT |
Primary outcome
Screen Positive Rate
Time frame: 0, 12, 24 months
Screen positive rate of LDCT based lung cancer screening in a high-risk Indian population
Screen positive rate for LDCT in the early detection of lung cancer in a high-risk Indian population
Time frame: 0, 12, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose CT in people with Lung Cancer, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abhishek Shankar, MD (+919968721213, doc.abhishankar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screen Positive Rate (time frame: 0, 12, 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.