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

A Study Assessing the Utility of Low-dose Computed Tomography (LDCT) in Lung Cancer Screening in North India

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: Low-dose computed tomography of chest

Detailed Description

Screening for lung cancer may reduce lung cancer mortality by diagnosing the disease at an early stage when it is treatable more effectively. There are several methods available for screening of lung cancer. These include sputum cytology, chest radiography, computed tomography (CT) of the chest, and positron emission tomography (PET). However, sputum cytology and chest radiography have been found to be ineffective as screening tests for lung cancer as there is no reduction in lung cancer mortality. The use of CT or PET for lung cancer screening may be associated with unacceptable levels of radiation exposure and enormous cost.

Low-dose computed tomography (LDCT) of the chest is a special type of CT, which uses relatively low radiation exposure to create a low-resolution image of the entire thorax. The radiation exposure associated with LDCT is 5-6 times less than that of a conventional CT scan of the thorax. LDCT screening has been to shown to result in a 20% reduction in lung cancer-specific mortality. Several national and international guidelines recommend this strategy for lung cancer screening.

Despite these guidelines and recommendations by several organizations, lung cancer screening has not been established in several developing countries, where a controversy arises due to high rates of granulomatous diseases like tuberculosis. Emerging evidence indicates that false positive results with LDCT in developing countries may not be unacceptably high as previously believed.

In this study, the investigators intend to assess the utility of lung cancer screening using low-dose computed tomography (LDCT) in India, a country with high prevalence of tuberculosis.

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Postgraduate Institute of Medical Education and Research (PGIMER)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals aged 55-74 years with at least 30 pack-year history of smoking (or smoking index ≥600) who are current smokers or quit within the last 15 years OR
• Individuals aged 50-74 years with at least 20 pack-year history of smoking (or smoking index ≥400) who are current or former smokers with COPD or family history of lung cancer in any first-degree relative

Exclusion Criteria:

• Symptomatic structural lung disease other than COPD (e.g. bronchiectasis, chronic pulmonary aspergillosis, pulmonary fibrosis)
• Severe comorbid condition which is likely to limit the survival of the patient in the opinion of the investigator (e.g. advanced lung disease, cardiovascular disease, chronic kidney disease, chronic liver disease)
• Presence of symptoms which lead to a suspicion of lung cancer (e.g. hemoptysis or unexplained weight loss [>5 kg] within the last 6 months)
• Conditions which may interfere interpretation of CT (e.g. metallic implants on chest wall, cardiac pacemakers)
• Treatment for any other cancer in the last 5 years
• Pulmonary infection (for which treatment with antimicrobials is indicated) which is active at present or was recent (within the last 3 months)
• Patients who have underwent CT chest within the last 18 months
• Negative consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LDCT arm; All eligible participants will undergo screening with LDCT	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; Other Names: LDCT; Low-dose CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positivity rate with LDCT screening	The proportion of participants with a positive result among the total number of individuals screened with LDCT	After baseline LDCT scan results are available (an average of 1 week after LDCT scan)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of detection of lung cancer	Rate of lung cancer detection among study participants	Up to 6 months after the LDCT scan
False positive rate	Rate of false positive results with LDCT screening	Up to 6 months after the LDCT scan
Proportion of patients requiring additional procedures (imaging/invasive procedures)	The proportion of patients with positive results on initial LDCT scan requiring additional procedures (imaging/invasive procedures)	Up to 6 months after the LDCT scan
Proportion of patients developing complications due to additional procedures	The proportion of patients among those who developed complications due to additional procedures (imaging/invasive procedures) performed after initial LDCT scan	Up to 2 weeks after the diagnostic procedure
Change in the 6-item Spielberger State-Trait Anxiety Inventory (STAI-6) questionnaire score	Change in anxiety levels from baseline after conveying LDCT results to the patient	After communication of baseline LDCT results (an average of 1-2 weeks after the LDCT scan)
Cost in Indian Rupees to detect one case of lung cancer by LDCT screening	Cost-effectiveness of LDCT screening	Up to 6 months after the LDCT scan
Proportion of patients who quit/re-initiated smoking after inclusion in study	The proportion of patients who quit/re-initiated smoking after inclusion in study	Up to 6 months after the LDCT scan

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Kuruswamy T Prasad, MD, DM, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh; Principal Investigator: Rajinder Basher, MD, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh; Principal Investigator: Mandeep Garg, MD, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh; Principal Investigator: Sandeep Grover, MD, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh; Principal Investigator: Naveen Kalra, MD, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh; Principal Investigator: Navneet Singh, MD, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh; Principal Investigator: Kathirvel Soundappan, MD, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 26, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: lung cancer; screening; lung nodule; ldct; low-dose CT
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: NK/5292/DM/760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No