Chest Imaging, Breath, and Biomarkers in a Screening Trial

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663155
• Other study ID #: 07-455
• Secondary ID: State of Ohio gr
• Status: Completed
• Phase: N/A
• First received: November 10, 2008
• Last updated: May 17, 2017
• Start date: September 2008
• Est. completion date: May 2014

Study information

• Verified date: May 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1424
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• chest x-ray with or without CAD, lose dose CT scan
PA view, low dose CT scan

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease-specific mortality between screening with chest x-ray and CAD versus no screening	Mortality rate in screening x-ray vs CAD	One year after scan
Secondary	All-cause mortality rate between screening with chest x-ray and CAD versus no screening	All cause mortality rate	One year after scan
Secondary	Length of time between randomization and the incidence of symptomatic advanced lung cancer for screened subjects versus controls	Time between randomization and symptom	One year after scan
Secondary	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	Cancer detection rate between chest x-ray and CAD	One year after scan
Secondary	The quality of life between screening with chest x-ray and CAD versus no screening.	Quality of life between the chest x-ray group and the CAD group	One year after scan