Utility of Biomarkers for Early Detection of Malignant Mesothelioma in a High-risk Population
- Abbreviated Name
- Lead Investigator
- Pass, Harvey Ira — New York University School of Medicine
- Coordinating Investigator
- Feng, Ziding — Fred Hutchinson Cancer Center
- Involved Investigators
A prospective study to evaluate the utility of various biomarkers in the context of an MM Early Detection Program. The study cohort will be composed of workers at a company with known asbestos exposure. Historically, a considerable number of workers at this company have developed MM.
Determine whether serial determination of osteopontin, mesothelin and fibulin-3, and HMGB1 in plasma samples can be used as biomarkers [sic] for early detection of MM in high-risk populations. Determine the utility of measuring levels of t hese biomarkers in pleural fluid samples from patients who develop pleural effusion. Determine the utility of these biomarkers for monitoring MM patients undergoing different treatment modalities. Create a plasma/serum/PAXgene/DNA sample "bank" that can be used for genetic and biomarker studies by researchers at participating institutions or other researchers worldwide.
Assuming 300-375 participants, a 0.5-1.0% per year incidence rate of MM, and three years of follow-up per participant, we project 4-11 incident cases of MM over the course of the study. This sample size will provide insufficient power to build and test models combining multiple markers. The study will have low power but will have the benefits of having a ProBE design with the ability to examine the time course of mark ers and their prognostic ability to detect MM prior to detection via chest CT scan. The performance of the individual markers (SMRP, osteopontin, fibulin-3, and HMGB1) at the time of a chest CT scan will be assessed by ROC curves. Blood measurements taken at a time that there is not a concurrent chest CT scan (e.g., mid-year blood draws without an 17 actionable SMRP level for which there would be no protocol-specified chest CT scan) will not be included in this analysis. The prognostic ability of markers will be assessed by ROC curves using marker values one or two years prior to the time of diagnosis of MM. For each marker, we will produce a plot of the ti me course of the marker for each individual with the time courses for cases of MM highlighted and the time of MM detection indicated, to develop hypotheses about the time course of marker values prior to MM detection, which in turn can be used to develop alternative marker decision rules (e.g ., based on SMRP trajectory) that incorporate longitudinal marker values. This analysis will be exploratory.
- No biomarkers available at this time for this protocol
- No data available at this time for this protocol
- Protocol ID
- Protocol Type
- Field of Research
- Collaborative Group
- Lung and Upper Aerodigestive Cancers Research Group
- Cancer Types
- Malignant neoplasm of bronchus and lung