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Soluble Mesothelin Related Peptide (SMRP) and Osteopontin (OPN) as Early Detection Markers for Malignant Mesothelioma (MM)
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Soluble Mesothelin Related Peptide (SMRP) and Osteopontin (OPN) as Early Detection Markers for Malignant Mesothelioma (MM)
Lung and Upper Aerodigestive Cancers Research Group
2
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.
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.
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
There are currently no biomarkers annotated for this protocol.
No datasets are currently associated with this protocol.
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