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

NCT ID: NCT01700257

Last Updated: 2020-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1361 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2020-12-07

Brief Summary

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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

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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.

Conditions

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High Risk of Developing Lung Cancer

Keywords

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Lung cancer screening Smokers or former smokers Family history of lung cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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CT scan & Early CDT Lung test

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

Group Type OTHER

CT scan & Early CDT Lung test

Intervention Type RADIATION

CT scan & Early CDT Lung test

Intervention Type OTHER

Interventions

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CT scan & Early CDT Lung test

Intervention Type RADIATION

CT scan & Early CDT Lung test

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Jewish Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James R Jett, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

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National Jewish Health

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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Oncimmune-2550

Identifier Type: -

Identifier Source: org_study_id