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

NCT03909620 | Completed

• 1 other identifier: NK/5292/DM/760
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

lung cancer; ldct; low-dose CT; screening; lung nodule

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rate of detection of lung cancer

  Up to 6 months after the LDCT scan

• False positive rate

  Up to 6 months after the LDCT scan

• Proportion of patients requiring additional procedures (imaging/invasive procedures)

  Up to 6 months after the LDCT scan

• Proportion of patients developing complications due to additional procedures

  Up to 2 weeks after the diagnostic procedure

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

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

Study Arms (1)

LDCT arm

EXPERIMENTAL

All eligible participants will undergo screening with LDCT

Diagnostic Test: Low-dose computed tomography of chest

Interventions

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

Also known as: LDCT, Low-dose CT

LDCT arm

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research (PGIMER)

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor, Department of Pulmonary Medicine

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 10, 2019
• Study Start: May 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: December 31, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)