Indian Lung Screening Trial

ConditionLung Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorAll India Institute of Medical Sciences

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals with a history of smoking at least 20 pack-years

either current smokers or those who quit within the last 15 years

Disqualifiers

Person who smoked fewer than 100 cigarettes in their lifetime

individuals currently receiving treatment for active cancer

Trial design

Design model

Single group

Treatments tested in this trial

  • Low dose CT

    Other intervention

    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.

Treatment groups

1,716 Participants
are divided into 1 treatment group
Group A: LDCTOther 1 intervention

Trial outcomes

Primary outcomes

1

Screen Positive Rate

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

Time frame
0, 12, 24 months
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

Secondary outcomes

Other outcomes

Sponsors and contacts

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