Chest Imaging, Breath, and Biomarkers in a Screening Trial

NCT01663155 | Completed DMC

• 3 other identifiers: 07-455State of Ohio grant06-055
• Study Type: observational
• Target: 1,424
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators would like to see if lung cancer screening with chest x-rays,computer aided detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more responsive to treatment. The investigators would also like to see if early detection will reduce the incidence of symptomatic advanced lung cancer compared to no screening in former and current smokers with or without a family history of lung cancer who are 40-75 years old.

Conditions

Lung Cancer

Keywords

lung cancer; chest x-ray; CT scan; computer aided detection (CAD); screening; smokers

Outcome Measures

Primary Outcomes (1)

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

  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.

  One year after scan

Secondary Outcomes (5)

• Disease-specific mortality between screening with chest x-ray and CAD versus no screening

  One year after scan

• All-cause mortality rate between screening with chest x-ray and CAD versus no screening

  One year after scan

• Length of time between randomization and the incidence of symptomatic advanced lung cancer for screened subjects versus controls

  One year after scan

• Does lung cancer screening with chest x-rays and computer aided detection (CAD) reduce the incidence of symptomatic advanced lung cancer in a high risk population

  One year after scan

• The quality of life between screening with chest x-ray and CAD versus no screening.

  One year after scan

Study Arms (1)

all enrolled subjects

Intervention is chest x-ray and CT scan. The chest x-ray image is read first without computer aided detection (CAD) and then a second time with computer aided detection (CAD) the CT scan is read by one reader. Subjects are asked to contribute breath and blood samples.

Device: chest x-ray with or without CAD, lose dose CT scan

Interventions

chest x-ray with or without CAD, lose dose CT scan DEVICE

PA view, low dose CT scan

Also known as: CAD, computer aided detection

all enrolled subjects

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care physicians or any other physician may refer potential candidates. Additionally, subjects may see marketing materials and contact the research team directly. There is no restriction to the area of residence of subjects.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

• Mazzone PJ, Obuchowski N, Fu AZ, Phillips M, Meziane M. Quality of life and healthcare use in a randomized controlled lung cancer screening study. Ann Am Thorac Soc. 2013 Aug;10(4):324-9. doi: 10.1513/AnnalsATS.201301-007OC.

  PMID: 23952850 DERIVED

• Mazzone PJ, Obuchowski N, Phillips M, Risius B, Bazerbashi B, Meziane M. Lung cancer screening with computer aided detection chest radiography: design and results of a randomized, controlled trial. PLoS One. 2013;8(3):e59650. doi: 10.1371/journal.pone.0059650. Epub 2013 Mar 20.

  PMID: 23527241 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood draw includes 2 10 mL red top tubes for serum retrieval, and 2 7 mL EDTA tubes for plasma and buffy coat retrieval

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Diagnostic Imaging; Diagnosis, Computer-Assisted

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Micheal Phillips, M.D.

  The Cleveland Clinic

  STUDY CHAIR

• Moulay Meziane, MD

  Chair of Thoracic Imaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: August 13, 2012
• Study Start: September 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 18, 2017

Record last verified: 2017-05

Locations

US (1)