Utility of LDCT in Lung Cancer Screening in a TB Endemic Region

NCT03909620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2022-03-29

No results posted yet for this study

Summary

Lung cancer screening with low-dose computed tomography (LDCT) has been recently shown to result in a significant reduction in lung cancer-specific mortality. However, the utility of LDCT screening in developing countries with high incidence of tuberculosis has not been adequately studied. The investigators hypothesize that LDCT screening in tuberculosis endemic regions is likely to yield a large proportion of false-positive results, especially in the initial round of screening, posing a significant burden on the healthcare system. Herein, the investigators assess the utility of LDCT and its cost-effectiveness in India.

Conditions

Interventions

DIAGNOSTIC_TEST

Low-dose computed tomography of chest

Eligible subjects will undergo a single round of LDCT screening. The LDCT will be considered as positive if a solid nodule or part-solid nodule of size ≥6 mm or non-solid nodule of size ≥20 mm is identified. Evaluation of positive nodules will be performed as per existing standard recommendations

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Kuruswamy T Prasad, MD, DM · Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

  • Rajinder Basher, MD · Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

  • Mandeep Garg, MD · Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

  • Sandeep Grover, MD · Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

  • Naveen Kalra, MD · Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

  • Navneet Singh, MD · Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

  • Kathirvel Soundappan, MD · Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-03-31
Completion
2021-12-31

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03909620 on ClinicalTrials.gov