Clinical trial NCT03909620: Utility of LDCT in Lung Cancer Screening in a TB Endemic Region
Official title: A Study Assessing the Utility of Low-dose Computed Tomography (LDCT) in Lung Cancer Screening in North India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
ldct
low-dose CT
screening
lung nodule
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2019-04-10
Enrollment: 253
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Positivity rate with LDCT screening
timeFrame: After baseline LDCT scan results are available (an average of 1 week after LDCT scan)
Secondary outcomes:
measure: Rate of detection of lung cancer
timeFrame: Up to 6 months after the LDCT scan
measure: False positive rate
timeFrame: Up to 6 months after the LDCT scan
measure: Proportion of patients requiring additional procedures (imaging/invasive procedures)
timeFrame: Up to 6 months after the LDCT scan
measure: Proportion of patients developing complications due to additional procedures
timeFrame: Up to 2 weeks after the diagnostic procedure
measure: Change in the 6-item Spielberger State-Trait Anxiety Inventory (STAI-6) questionnaire score
timeFrame: After communication of baseline LDCT results (an average of 1-2 weeks after the LDCT scan)
measure: Cost in Indian Rupees to detect one case of lung cancer by LDCT screening
timeFrame: Up to 6 months after the LDCT scan
measure: Proportion of patients who quit/re-initiated smoking after inclusion in study
timeFrame: Up to 6 months after the LDCT scan
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research (PGIMER)
Study officials:
affiliation: Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
name: Kuruswamy T Prasad, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
name: Rajinder Basher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
name: Mandeep Garg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
name: Sandeep Grover, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
name: Naveen Kalra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
name: Navneet Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
name: Kathirvel Soundappan, MD
role: PRINCIPAL_INVESTIGATOR
References: