Indian Lung Screening Trial

NCT07590440 | Not Yet Recruiting

• 1 other identifier: AIIMSA5189/07.11.2025
• Study Type: interventional
• Target: 1,716
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung Cancer; Screening; Early detection

Outcome Measures

Primary Outcomes (2)

• Screen Positive Rate

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

  0, 12, 24 months

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

  0, 12, 24 months

Study Arms (1)

LDCT

OTHER

Low Dose CT Scan for lung cancer screening

Other: Low dose CT

Interventions

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.

LDCT

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

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

Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Abhishek Shankar, MD

CONTACT

+919968721213; doc.abhishankar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)