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

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National Jewish Health

Status

Completed

Conditions

High Risk of Developing Lung Cancer

Treatments

Other: CT scan & Early CDT Lung test

Study type

Interventional

Funder types

Other

Identifiers

NCT01700257
Oncimmune-2550

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,361 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,361 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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