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A Clinical Trial to Develop Chest Imaging, Breath, and Biomarkers in a Screening Trial


N/A
40 Years
75 Years
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

A Clinical Trial to Develop Chest Imaging, Breath, and Biomarkers in a Screening Trial


The fight against lung cancer is waged on three major fronts: prevention, detection and
treatment. Our goal is to determine if chest x-rays,computer aided detection (CAD)and a CT
scan can detect disease earlier when treatment is more effective. If we improve the
detection of disease, we will see if screening reduces the incidence of symptomatic advanced
lung cancer relative to no screening in people at high risk to develop lung cancer.


Inclusion Criteria:



- ages 40-75 years

- If ages 40-59, then one of the following criteria needs to be met:

- Current or ex-smoker with >25 pack years and a family history of lung
cancer(parent or sibling) OR

- current or ex-smoker with > 25 pack years and COPD OR

- current or ex-smoker with a > 35 pack year history

- If ages 60-75, then one of the following additional criteria needs to be met:

- Current or ex-smoker with >25 pack years and a family history of lung cancer
(parent or sibling) OR

- Current or ex-smoker with >25 pack years and COPD OR

- Current or ex-smoker with a >30 pack year history

- Subject is able to return to Cleveland Clinic for annual follow-up screening

- Subject is willing to sign a medical release form

Exclusion Criteria:

- Current health requires oxygen

- Have had a chest x-ray or CT of the chest within the last 6 months

- Previous pneumonectomy

- Lobectomy of the lung within the last 5 years

- Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer,
carcinoma in situ of the cervix and localized prostate cancer

- A medical condition that would prevent treatment for lung cancer

- Within the last 6 weeks, one of the following has occured:

- A new cough or chronic cough that has gotten worse

- Either new shortness of breath, or any worsening of shortness of breath

- A cough producing blood

- Constant chest pain

- Respiratory infection, pneumonia, or cold

- Unintentional and unexplained weight loss greater than 5% of total body weight

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The sensitivities of chest x-ray with CAD and chest CT

Outcome Description:

The false positive rates of chest x-ray with CAD and chest CT will be compared. The analysis will be based on the study subjects from this prospective study who test positive with chest x-ray and/or CT and who are determined not to have lung cancer during the follow-up period.

Outcome Time Frame:

March, 2012 for scanning results only

Safety Issue:

No

Principal Investigator

Micheal Phillips, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Institutional Review Board

Study ID:

07-455

NCT ID:

NCT01663155

Start Date:

September 2008

Completion Date:

March 2013

Related Keywords:

  • Lung Cancer
  • lung cancer
  • chest x-ray
  • CT scan
  • computer aided detection (CAD)
  • screening
  • smokers
  • Lung Neoplasms

Name

Location

Cleveland ClinicCleveland, Ohio  44195