Lung CancerNCT03909620
Utility of LDCT in Lung Cancer Screening in a TB Endemic Region
A study testing Low-dose computed tomography of chest in people with Lung Cancer, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Low-dose computed tomography of chest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education and Research (PGIMER)
Chandigarh, 160012
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Low-dose computed tomography of chest
- Keywords
- lung cancer, ldct, low-dose CT, screening, lung nodule
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose computed tomography of chestDiagnostic test
Also called LDCT, Low-dose CT
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
| Study group | Role | What they receive |
|---|---|---|
| LDCT arm | Experimental | All eligible participants will undergo screening with LDCT Receives: Diagnostic Test: Low-dose computed tomography of chest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positivity rate with LDCT screening
The proportion of participants with a positive result among the total number of individuals screened with LDCT
Measured: After baseline LDCT scan results are available (an average of 1 week after LDCT scan)
Secondary outcomes (7)
Rate of detection of lung cancer
Rate of lung cancer detection among study participants
Measured: Up to 6 months after the LDCT scan
False positive rate
Rate of false positive results with LDCT screening
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 6 months after the LDCT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 May 2019
- Primary completion31 Mar 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Navneet Singh, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Kuruswamy T Prasad, MD, DM, Principal investigator, Postgraduate Institute of Medical Education and Research (PGIMER), ChandigarhRajinder Basher, MD, Principal investigator, Postgraduate Institute of Medical Education and Research (PGIMER), ChandigarhMandeep Garg, MD, Principal investigator, Postgraduate Institute of Medical Education and Research (PGIMER), ChandigarhSandeep Grover, MD, Principal investigator, Postgraduate Institute of Medical Education and Research (PGIMER), ChandigarhNaveen Kalra, MD, Principal investigator, Postgraduate Institute of Medical Education and Research (PGIMER), ChandigarhNavneet Singh, MD, Principal investigator, Postgraduate Institute of Medical Education and Research (PGIMER), ChandigarhKathirvel Soundappan, MD, Principal investigator, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909620
- Sponsor's protocol ID
- NK/5292/DM/760
- Status last verified
- Mar 2022
- First submitted
- 5 Apr 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Assessing the Utility of Low-dose Computed Tomography (LDCT) in Lung Cancer Screening in North India
- ClinicalTrials.gov ID
- NCT03909620
- Acronym / sponsor ID
- NK/5292/DM/760
- Conditions
- Lung Cancer
- Keywords
- lung cancer, ldct, low-dose CT, screening, lung nodule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDCT arm | Experimental | Diagnostic Test: Low-dose computed tomography of chestAll eligible participants will undergo screening with LDCT |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose computed tomography of chestAlso: LDCT, Low-dose CTEligible 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 | Diagnostic test | LDCT arm |
Primary outcome
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
7 secondary outcomes
Rate of detection of lung cancer
Time frame: Up to 6 months after the LDCT scan
False positive rate
Time frame: Up to 6 months after the LDCT scan
Proportion of patients requiring additional procedures (imaging/invasive procedures)
Time frame: Up to 6 months after the LDCT scan
Proportion of patients developing complications due to additional procedures
Time frame: Up to 2 weeks after the diagnostic procedure
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)
Cost in Indian Rupees to detect one case of lung cancer by LDCT screening
Time frame: Up to 6 months after the LDCT scan
Proportion of patients who quit/re-initiated smoking after inclusion in study
Time frame: Up to 6 months after the LDCT scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuruswamy T Prasad, MD, DM principal investigator
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Rajinder Basher, MD principal investigator
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Mandeep Garg, MD principal investigator
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose computed tomography of chest in people with Lung Cancer, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positivity rate with LDCT screening (time frame: After baseline LDCT scan results are available (an average of 1 week after LDCT scan)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.