NCT03683940

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

6.7 years

First QC Date

September 24, 2018

Last Update Submit

December 11, 2023

Conditions

Lung Cancer

Keywords

Pilot StudyHigh RiskProspectiveScreening

Outcome Measures

Primary Outcomes (5)

  • Lung Cancer Screening

    Prospectively identify patients for lung cancer screening using risk calculators

    Duration of the study, up to 3 years

  • Medical Outcomes

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

    Duration of the study, up to 3 years

  • Medical Outcomes

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

    Duration of the study, up to 3 years

  • Economic Outcomes

    Evaluate the costs associated with managing lung cancers detected by screening

    Duration of the study, up to 3 years

  • Economic Outcomes

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

    Duration of the study, up to 3 years

Study Arms (1)

Screening

OTHER

Subjects will undergo a low dose non contrast CT chest for lung cancer screening.

Diagnostic Test: Screening

Interventions

ScreeningDIAGNOSTIC_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.

Screening

Eligibility Criteria

Age40 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Denver, Colorado, 80045, United States

Location

Related Publications (1)

  • Hirsch EA, New ML, Brown SL, Malkoski SP. Results of a pilot risk-based lung cancer screening study: outcomes and comparisons to a Medicare eligible cohort. Discov Oncol. 2023 Aug 29;14(1):160. doi: 10.1007/s12672-023-00773-5.

    PMID: 37642787DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Melissa New, MD

    University of Colorado, Denver

    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
SPONSOR

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 25, 2018

Study Start

August 10, 2016

Primary Completion

April 25, 2023

Study Completion

November 9, 2023

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations

US(1)