Abbreviated Name

MESOTHELIOMA

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
• Rom, William — New York University School of Medicine
• Chia (Retired), David — University of California Los Angeles
• Robinson, Bruce — University of Western Australia
• Zheng, Yingye — Fred Hutchinson Cancer Center

Abstract

Validation of SMRP and OPN, individually and in combination, as biomarkers for Malignant Mesothelioma (MM).

Aims

Phase I: - Identification and assemblage of representative cohorts of individuals with MM, no malignancies but increased risk for MM due to asbestos exposure, and (optionally) lung malignancies other than MM Phase II (A) - Determine the sensitivity and specificity of SMRP and OPN in distinguishing individuals with a clinical diagnosis of malignant mesothelioma from individuals who are asbestos-exposed but without a clinical diagnosis of malignant mesothelioma. Phase II (B) – Determine the comparability of analyte values across contributing centers and determine covariates that influence analyte levels Phase II (C) – Determine the sensitivity and specificity of SMRP and OPN, alone and in combination, in distinguishing individuals with MM from those without. Phase III. Determine the sensitivity and specificity of SMRP and OPN in distinguishing individuals who would subsequently develop malignant mesothelioma from matched individuals who did not subsequently develop malignant mesothelioma. Phase IV. Determine the sensitivity and specificity of SMRP and OPN in other populations of interest.

Analytic Method

The form of the final analysis will not be determined until the end of Phase II (B). To arrive at an initial estimate of the power for this phase, we analyze the power we would have if the data from all contributing sites can be combined and there are no covariates that will need to be included in the analysis. With a total of 164 cases and 687 controls, using 80% power and with a 2-sided, 0.05-level test, the following tables show the differences in sensitivity and specificity that are detectable: Table 1. Sensitivity detectable with 80% power in a joint analysis of sensitivity and specificity Null Hypothesis Sensitivity 0.10 0.25 0.50 0.75 Detectable Sensitivity   0.18 0.36 0.62   0.85 Table 2. Specificity detectable with 80% power in a joint analysis of sensitivity and specificity Null Hypothesis Specificity 0.50 0.80 0.90 0.95 Detectable Specificity   0.52 0.85 0.94   0.98

Publications

• No publications available at this time for this protocol.

Biomarkers

• EFEMP1
• HMGB1
• Osteopontin
• SMRP

Data Collections

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

Start Date

Mar 16 2009

Estimated Finish Date

Mar 16 2010

Finish Date

May 31 2010

Protocol ID

136

Protocol Type

Validation

Fields of Research

• Proteomics

Collaborative Group

Lung and Upper Aerodigestive Cancers Research Group

Cancer Types

• Malignant neoplasm of bronchus and lung

Phased Status

2