Abbreviated Name

Chile-US

Lead Investigator

Pass, Harvey Ira — New York University School of Medicine

Coordinating Investigator

Zheng, Yingye — Fred Hutchinson Cancer Center

Involved Investigators

• Pass, Harvey Ira — New York University School of Medicine
• Srivastava, Sudhir — National Cancer Institute
• Zheng, Yingye — Fred Hutchinson Cancer Center

Abstract

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.

Aims

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.

Analytic Method

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.

Outcome

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.

Publications

• No publications available at this time for this protocol.

Biomarkers

• No biomarkers available at this time for this protocol.

Data Collections

• No data collections available at this time for this protocol.

Start Date

Dec 1 2013

Estimated Finish Date

Dec 31 2018

Finish Date

Aug 14 2019

Protocol ID

381

Protocol Type

Validation

Fields of Research

• Epigenomics
• Proteomics

Collaborative Group

Lung and Upper Aerodigestive Cancers Research Group

Cancer Types

• Malignant neoplasm of bronchus and lung