ung cancer screening in heavy smokers

Not Applicable

• Registration Number: CTRI/2022/01/039655
• Lead Sponsor: Datar Cancer Genetics Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Inclusion Criteria for Cohort A (Heavy Smokers)

1.Male or female volunteer aged 40 years and above

2.Heavy (e.g., >20 pack-year) smoking history including current smokers or those have quit smoking within the past 15 years.

3.Agreeing to participate in the study by giving written informed consent

Inclusion Criteria for Cohort B (High Risk, but not Heavy Smokers)

1.Male or female volunteer aged 40 years and above

2.Less than 20 pack-year smoking history, including current smokers or those who have quit smoking within the past 15 years.

3.Agreeing to participate in the study by giving written informed consent

4.Having at least one of the following risk factors:

i) Family history of lung cancer in first degree relatives, in which case younger patients (30 years and above) could be recruited

ii) Environmental (passive) tobacco smoking history for past

iii) Chronic lung disease, namely, tuberculosis or chronic obstructive pulmonary disease, Emphysema, Interstitial lung disease, such as pulmonary fibrosis

iv) Occupational and environmental exposures, such as asbestos, arsenic, beryllium, cadmium, chromium, coal smoke, diesel fumes, nickel, silica, and soot

v) High levels of radon exposure

Exclusion Criteria

Exclusion Criteria (Common for Cohort A and Cohort B)

1.Inability to provide Informed Consent

2.Inability to undergo LDCT scans

3.Prior diagnosis of any cancer

4.Being pregnant

5.Having previously undergone radiation therapy to the chest

6.Conditions which may interfere in the interpretation of CT (e.g., metallic implants on chest wall, cardiac pacemakers)

7.Patients who have undergone CT chest within the last 18 months

8.Comorbidities which may hamper feasibility of lung biopsy

9.History of removal of any portion of the lung, excluding needle biopsy

10.Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of these criteria must be reported in accordance with IEC Policies and Procedures.

Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of these criteria must be reported in accordance with IEC Policies and Procedures.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To detect sensitivity of TruCheck to detect HPE positive lung cancer cases from the study cohort.Timepoint: 3 years

Secondary Outcome Measures

Name	Time	Method
1) To detect specificity of TruCheck to detect HPE positive lung cancer cases from the study cohort. <br/ ><br>2) To determine if TruCheck can assist in triaging of LDCT Positive: suspicious for lung cancer cases for further invasive biopsies <br/ ><br>3) To determine performance of TruCheck as a screening solution in study population <br/ ><br>4) Safety offered by non-invasive nature of TruCheck analysis over LDCT and physical biopsy/FNAC/tissue sampling procedure. <br/ ><br>Timepoint: 3 years