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Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker

Primary Purpose

High Risk of Developing Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT scan & Early CDT Lung test
CT scan & Early CDT Lung test
Sponsored by
National Jewish Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for High Risk of Developing Lung Cancer focused on measuring Lung cancer screening, Smokers or former smokers, Family history of lung cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Smokers or former smokers
  • At least 20 pack year history of smoking
  • Ages 50 - 75

Exclusion Criteria:

  • Had a CT scan of chest within last 24 months
  • History of any cancer within 10 yrs (except skin cancer or cervical cancer)
  • A serious illness that decreases life expectancy to less than 5 years
  • Any current use of Oxygen
  • Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion
  • Severe COPD or dyspnea that would prevent lung surgery or stereotactic body radiotherapy

Sites / Locations

  • National Jewish Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CT scan & Early CDT Lung test

Arm Description

Every study participant receives a CT scan & Early CDT-Lung test (biomarker blood test) for lung cancer screening purposes.

Outcomes

Primary Outcome Measures

CT alone vs. both Early CDT-Lung test and CT scan.
Assess the number of lung cancers detected with CT alone vs. with both Early CDT-Lung test and CT scan. Compare positive CT results with positive/negative Early CDT Lung test results and assess ability of the combination to detect earlier stage lung cancer.

Secondary Outcome Measures

Value of Early CDT-lung test in detecting cancer
Assess the value of Early CDT-lung test in detecting lung cancer in individuals who are CT scan negative but positive for Early CDT-lung.

Full Information

First Posted
October 2, 2012
Last Updated
December 29, 2020
Sponsor
National Jewish Health
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1. Study Identification

Unique Protocol Identification Number
NCT01700257
Brief Title
Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker
Official Title
Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Jewish Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer deaths are not prevented with LDCT screening alone.
Detailed Description
In this trial, the addition of a blood biomarker test is being combined with early LDCT to determine if screening with combination may result in detection of more lung cancer at an earlier stage of disease.The study will also assess if the blood test is able to detect lung cancers in high risk individuals when the LDCT is negative for cancer. There will be health-economic costs included in the final analysis of study data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Risk of Developing Lung Cancer
Keywords
Lung cancer screening, Smokers or former smokers, Family history of lung cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1361 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT scan & Early CDT Lung test
Arm Type
Other
Arm Description
Every study participant receives a CT scan & Early CDT-Lung test (biomarker blood test) for lung cancer screening purposes.
Intervention Type
Radiation
Intervention Name(s)
CT scan & Early CDT Lung test
Other Intervention Name(s)
Every study participant receives a CT scan & Early CDT-Lung test (biomarker blood test), for lung cancer screening purposes
Intervention Type
Other
Intervention Name(s)
CT scan & Early CDT Lung test
Other Intervention Name(s)
CT scan & Early CDT-Lung test (biomarker blood test)for lung cancer screening.
Primary Outcome Measure Information:
Title
CT alone vs. both Early CDT-Lung test and CT scan.
Description
Assess the number of lung cancers detected with CT alone vs. with both Early CDT-Lung test and CT scan. Compare positive CT results with positive/negative Early CDT Lung test results and assess ability of the combination to detect earlier stage lung cancer.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Value of Early CDT-lung test in detecting cancer
Description
Assess the value of Early CDT-lung test in detecting lung cancer in individuals who are CT scan negative but positive for Early CDT-lung.
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Health Economics
Description
Comparison of the health economic costs of Early CDT-Lung test and CT scan when each is used individually or in combination.
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Smokers or former smokers At least 20 pack year history of smoking Ages 50 - 75 Exclusion Criteria: Had a CT scan of chest within last 24 months History of any cancer within 10 yrs (except skin cancer or cervical cancer) A serious illness that decreases life expectancy to less than 5 years Any current use of Oxygen Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion Severe COPD or dyspnea that would prevent lung surgery or stereotactic body radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R Jett, MD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States

12. IPD Sharing Statement

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Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker

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