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Completed

NCT Number: NCT03909620

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

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.

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Key information

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Postgraduate Institute of Medical Education and Research (PGIMER)

Chandigarh, 160012, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose computed tomography of chest

Diagnostic Test

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

Primary outcomes

  1. Positivity rate with LDCT screening

    Time frame: After baseline LDCT scan results are available (an average of 1 week after LDCT scan)

    The proportion of participants with a positive result among the total number of individuals screened with LDCT

Secondary outcomes

  1. Rate of detection of lung cancer

    Time frame: Up to 6 months after the LDCT scan

    Rate of lung cancer detection among study participants

  2. False positive rate

    Time frame: Up to 6 months after the LDCT scan

    Rate of false positive results with LDCT screening

  3. Proportion of patients requiring additional procedures (imaging/invasive procedures)

    Time frame: Up to 6 months after the LDCT scan

    The proportion of patients with positive results on initial LDCT scan requiring additional procedures (imaging/invasive procedures)

  4. Proportion of patients developing complications due to additional procedures

    Time frame: Up to 2 weeks after the diagnostic procedure

    The proportion of patients among those who developed complications due to additional procedures (imaging/invasive procedures) performed after initial LDCT scan

  5. Change in the 6-item Spielberger State-Trait Anxiety Inventory (STAI-6) questionnaire score

    Time frame: After communication of baseline LDCT results (an average of 1-2 weeks after the LDCT scan)

    Change in anxiety levels from baseline after conveying LDCT results to the patient

  6. Cost in Indian Rupees to detect one case of lung cancer by LDCT screening

    Time frame: Up to 6 months after the LDCT scan

    Cost-effectiveness of LDCT screening

  7. Proportion of patients who quit/re-initiated smoking after inclusion in study

    Time frame: Up to 6 months after the LDCT scan

    The proportion of patients who quit/re-initiated smoking after inclusion in study

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 10, 2019
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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