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Completed

NCT Number: NCT03683940

Pilot Study of High Risk Lung Cancer Screening

This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines.

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Key information

Conditions

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

Age range

40 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Denver, Colorado, 80045, United States

About this study

This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines. Potential subject's 6 yr lung cancer risk must exceed 1.5% by the Tammamagi PLCO2012m calculator. Patients will undergo a non contrast CT chest for lung cancer screening. This cutoff should encompass in excess of 80% of all lung cancer cases (10). However, in patients 78-82 years old we will set the 6 yr lung cancer risk threshold at 4.0% as these patients will typically have other competing risks of death and this may potentially limit screening benefit in these older individuals.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult 40-82 yrs of age.
  • Presenting for lung cancer screening evaluation.
  • Calculated 6 yr lung cancer risk >1.5% for patients 40-77 years of age or >4% for patients 78-82 years of age.
  • Able and willing to provide informed consent.

Exclusion criteria

  • Eligible for clinically indicated lung cancer screening (55-80 yr old, >30 pky smoking history, still smoking or quit smoking within the last 15 yr).
  • Chest CT performed within the last year.
  • Life expectancy less than 6 months.
  • Symptoms clinically consistent with lung cancer.
  • Unable or unwilling to undergo treatment for lung cancer.
  • Any individual who does not give oral and written consent for participation.

Treatment and study plan

Screening

Diagnostic Test

Subjects will undergo a low dose non contrast CT chest for lung cancer screening. The test will be performed by the UCH Radiology Department and read by board-certified chest radiologists using Lung-RADS criteria.

Primary outcomes

  1. Lung Cancer Screening

    Time frame: Duration of the study, up to 3 years

    Prospectively identify patients for lung cancer screening using risk calculators

  2. Medical Outcomes

    Time frame: Duration of the study, up to 3 years

    Evaluate health outcomes of CT screening by assessing the number and stage of lung cancers detected by screening using Lung-RADS criteria

  3. Medical Outcomes

    Time frame: Duration of the study, up to 3 years

    Evaluate health outcomes of CT screening by assessing the number and stage the spectrum of other radiographic abnormalities detected using Lung-RADS criteria

  4. Economic Outcomes

    Time frame: Duration of the study, up to 3 years

    Evaluate the costs associated with managing lung cancers detected by screening

  5. Economic Outcomes

    Time frame: Duration of the study, up to 3 years

    Evaluate the costs associated with managing the spectrum of other radiographic abnormalities

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

A Prospective Pilot Study of Lung Cancer Screening in Patients at High Risk for Lung Cancer Who Do Not Meet Current Screening Guidelines

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2018
Registry last updated
Dec 12, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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