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NCT Number: NCT07590440

Indian Lung Screening Trial

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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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Bhimrao Ambedkar Institute Rotary Cancer Hospital, AIIMS, New Delhi, India

Delhi, National Capital Territory of Delhi, 110029, India

Location contact

Abhishek Shankar, MD

CONTACT

[email protected]

+919968721213

Abhishek Shankar, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with a history of smoking at least 20 pack-years
  • either current smokers or those who quit within the last 15 years

Exclusion criteria

  • Person who smoked fewer than 100 cigarettes in their lifetime
  • individuals currently receiving treatment for active cancer

Treatment and study plan

Low dose CT

Other

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.

Primary outcomes

  1. Screen Positive Rate

    Time frame: 0, 12, 24 months

    Screen positive rate of LDCT based lung cancer screening in a high-risk Indian population

  2. Screen positive rate for LDCT in the early detection of lung cancer in a high-risk Indian population

    Time frame: 0, 12, 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Abhishek Shankar, MD

CONTACT

[email protected]

+919968721213

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study 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

Acronym: ILST

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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