Indian Lung Screening Trial

Официальное название

Evaluating the Effectiveness of Low-dose CT Based Lung Cancer Screening Among High-risk Individuals and Availability and Impact of Lung Cancer Care Pathways

Обзор

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.

Вмешательства

• Другое Low dose CT
  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 C

Первичные конечные точки

• Screen Positive Rate [Срок оценки: 0, 12, 24 months]
• Screen positive rate for LDCT in the early detection of lung cancer in a high-risk Indian population [Срок оценки: 0, 12, 24 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Индия · 1 центр

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

Идентификаторы

NCT: NCT07590440 · AIIMSA5189/07.11.2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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