Early Diagnosis of Lung Cancer and Mesothelioma in Prior Asbestos Workers

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188890
First received: September 12, 2005
Last updated: March 17, 2016
Last verified: March 2016
  Purpose
Occupational exposure to asbestos is known increase the risk of developing cancer of the lungs (bronchogenic carcinoma) or of the pleura (mesothelioma). Symptoms are subtle and non-specific, diagnosis is often late and the prognosis consequently is dismal. Currently there is no accepted non-invasive tool for the early diagnosis of mesothelioma or lung cancer in asbestos-exposed subjects. In the last decade, low-dose computed tomography (LDCT) has been successfully developed and validated for the early diagnosis of lung cancer in high-risk smokers. Malignant mesothelioma might, in an early stage, resemble a benign pleural plaque, which is a common finding after asbestos exposure. We target to develop low-dose CT as a tool to serially image the pleural plaques, quantify their individual and overall volume, compute the growth rate with time, and, as such, identify the presence of mesothelioma early, before symptoms occur.

Condition
Lung Cancer
Mesothelioma

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Early Diagnosis of Mesothelioma and Lung Cancer Following Asbestos Exposure Using Low-dose Computed Tomography

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Estimated Enrollment: 2000
Study Start Date: March 2005
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
prior occupational exposure at least 20 years ago to ASBESTOS and / or documented pleural plaques on a chest x-ray Must be 30 years of age or older. NO prior cancers, except non-melanic skin cancers

Detailed Description:

Background and Purpose:

Asbestos exposure may result in several different diseases to the lung and to the lining of the lung, the so-called pleura. Mostly they are benign, but there are two common malignant diseases in people with prior asbestos exposure, the so-called mesothelioma - which originates from the pleura - and cancer of the lung. Symptoms of any of these malignant diseases generally do not appear for 10-35 years after the first asbestos exposure, and include shortness of breath, chronic or new cough, coughing of blood, chest pain or weight loss. Unfortunately, these symptoms are most often causes by very advanced diseases, when patients can no longer be cured. Currently there is no accepted tool for the early diagnosis of mesothelioma or lung cancer in asbestos-exposed subjects available. Standard of care includes regular chest radiographs, which are not sufficient to show mesothelioma or lung cancer in an early stage.

A screening CT examination, also called CAT scan, of the lungs will be performed without intravenous contrast. The CT examination as such is not an experimental procedure, CAT scans are performed routinely since decades. However, in this particular case, this albeit standard examination is performed for the purposes of research only, it is not part of standard of care. The screening CT examination of the lungs takes less than 10-20 minutes to perform.

If no abnormalities are found on the initial examinations, you will be examined with one repeat screening CT of the chest after one year.

If pleural plaques or a nodule in the lungs is seen on your baseline CT, this will lead to further testing. Quite likely (approximately 1 in 3 chance), you will be invited for a follow-up CT 3 or 6 months. Further investigations will be chosen according to standard of care and will be explained to you at the time. These will be coordinated by your physician with Dr. Marc de Perrot, Department of Thoracic Surgery.

Secondly, there is evidence in other types of cancers such as cancers of the prostate and ovary, that analysis of blood may reveal protein markers that indicate the presence of cancer in the body. A companion blood analysis study is being undertaken in an effort to discover such markers for lung cancer and mesothelioma, so that the accuracy of CT-scan diagnosis for lung cancer may be further improved.

Both at the time of your baseline screening CT and at your annual follow-up screening CT, you will be asked to provide 5 ml (approximately 2 teaspoons full) blood sample through a needle stick. A blood-taking technician employed by the University Health Network or a certified nurse will carry out this procedure. Purpose of this study is to search in the blood for so-called "markers", substances in the blood which indicate that there is a cancer in the lungs or pleura.

Most of these markers are still in development, thus your blood will be stored and analyzed at a future date.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
prior exposure to asbestos and or documented pleural plaques
Criteria

Inclusion Criteria:

prior asbestos exposure at least 20 years ago and/or documented pleural plaques (chest x-ray evidence)

Resident of Ontario, Canada

Exclusion Criteria:

prior cancer (except non-melanotic skin cancer)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188890

Contacts
Contact: Demetris Patsios, MD Tel: (416) 603-5800 ext 2583 demetris.patsios@uhn.on.ca
Contact: Brenda O'Sullivan 416-340-4800 ext 5686 Brenda.O'Sullivan@uhn.on.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada
Contact: Demetris Patsios, MD    Tel: (416) 603-5800 ext 2583    demetris.patsios@uhn.on.ca   
Contact: Brenda O'Sullivan, MD    416-340-4800 ext 5686    brenda.o'sullivan@uhn.on.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Demetris Patsios, MD University Health Network, Toronto
Principal Investigator: Marc de Perrot, MD University Health Network, Toronto
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188890     History of Changes
Other Study ID Numbers: Asbestos Screening Study 
Study First Received: September 12, 2005
Last Updated: March 17, 2016
Health Authority: Canada: Health Canada
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University Health Network, Toronto:
Lung Cancer
Mesothelioma
Asbestos
Screening
Early Diagnosis

Additional relevant MeSH terms:
Lung Neoplasms
Mesothelioma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on July 27, 2016