AIRCARE (Air Pollution and Cancer Research Ecosystem): Center for Advanced Research on Environmental Health and Lung Cancer Risk

NCT07553598 | Not Yet Recruiting

• 1 other identifier: AIIMSA5193/07.11.2025
• Study Type: observational
• Target: 3,230
• Locations: 1 country
• Sites: 1

Brief Summary

In India, lung cancer is the 2nd most common in males and 4th overall in cancer incidence with 81,784 new cases and 75,031 deaths with a 5-year prevalence of 1,13,990 as per GLOBOCAN 2022. Air pollution, particularly fine particulate matter (PM2.5), has been identified as a significant risk factor for lung cancer in never-smokers. India is showing an increasing incidence of lung cancer and there is a need to understand air pollution given many cities in India have been reported to be the most polluted in the world. Evidence of causal associations between PM2.5 and an increased likelihood of lung cancer with underlying biological mechanisms are now fully known. Current evidence focuses on individual pollutants, overlooking potential interactions among multiple risk factors that could amplify lung cancer risks. There is paucity of data on vulnerability of groups like children, older adults, and individuals with pre-existing health conditions, who may face disproportionate risks from poor air quality. The long-term effects of chronic exposure to air pollutants and their cumulative contribution to lung cancer risk remain understudied. Centre for Advanced Research on AIRCARE is essential to bridge these research gaps, providing a holistic understanding of air pollution's role in lung cancer to plan prevention and policy strategies. The study will be conducted at AIIMS, Delhi, and areas in Delhi and NCR with varying levels of PM 2.5 exposure and will encompass regions with diverse socio-economic profiles and industrial activities to capture the heterogeneity of exposure and risk. Subjects and controls will be enrolled to ensure a suitable representation of various demographic, socio-economic and air pollution exposure parameters. A subset of the cohort will be selected for genotyping, focusing on individuals with extreme exposure levels and/or lung cancer cases and controls for genetic interaction studies.

Conditions

Lung Cancer

Keywords

air pollution; lung cancer; biomarkers; risk

Outcome Measures

Primary Outcomes (4)

• PM 2.5 exposure

  The primary outcome will be measured in terms of histologically confirmed incidence of lung cancer. The interaction effects between air pollution (PM2.5) and other risk factors (smoking, Alcohol consumption, occupational exposures, genetic susceptibility) on lung cancer incidence and cumulative risk of lung cancer associated with combined exposure to air pollution and other risk factors will be evaluated.

  3 years

• Risk Stratification Model

  The primary outcome will be measured based on the performance of the risk stratification model in predicting lung cancer risk, assessed by area under the receiver operating characteristic (AUROC) curve, sensitivity and specificity at predefined risk thresholds, and using calibration plots, to assess the agreement between predicted and observed risks.

  3 years

• Biomarker Identification

  Primary Outcome will be measured by identification of biomarkers that are significantly associated with air pollution-related lung cancer, and the predictive ability of the biomarkers to discern between cases and controls.

  3 years

• Identifying Vulnerable Groups

  Primary Outcome will be measured with differences in lung cancer incidence rates across vulnerable subgroups, and hazard ratios for lung cancer associated with air pollution exposure in each vulnerable subgroup.

  3 years

Secondary Outcomes (4)

• Exposure Interaction Effects

  3 years

• Modelling Epidemiology

  3 years

• Variation in Biomarker Levels

  3 years

• Characterisation of Vulnerable Groups

  3 years

Study Arms (2)

Patients

Patients with Lung Cancer

Control

Age-, Sex- and Residence-matched individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enrol an estimated 3230 participants (1615 lung cancer cases and 1615 controls). Diagnosed lung cancer cases from the outpatient department and Delhi cancer registry (DCR) will be included. Controls will be recruited from the family members of lung cancer patients to get the matched population in terms of PM 2.5 exposure.

You may qualify if:

• Adults aged 18 years or older, Histologically confirmed diagnosis of lung cancer, Residing in Delhi/National Capital Region (NCR)

You may not qualify if:

• Individuals aged below 18 years, individuals without a histologically confirmed diagnosis of lung cancer

Sponsors & Collaborators

• Abhishek Shankar: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

All India Institute of Medical Sciences

New 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

+91 9968721213; doc.abhishankar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)