Presentation at the EDRN FDA Training Workshop February 15, 2007 Imprint Thornquist Co-PI, EDRN Information Administrati.


130 views
Uploaded on:
Category: News / Events
Description
Factual Contemplations for Dissolvable Mesothelin Related Peptide (SMRP) and Osteopontin (OPN) as Early Discovery Markers for Dangerous Mesothelioma (MM) Presentation at the EDRN FDA Training Workshop February 15, 2007 Imprint Thornquist Co-PI, EDRN Information Administration and Planning Center
Transcripts
Slide 1

Factual Considerations for Soluble Mesothelin Related Peptide (SMRP) and Osteopontin (OPN) as Early Detection Markers for Malignant Mesothelioma (MM) Presentation at the EDRN FDA Education Workshop February 15, 2007 Mark Thornquist Co-PI, EDRN Data Management and Coordinating Center

Slide 2

Phases Phase I: Identification and union of example sets of instances of dangerous mesothelioma, asbestos-uncovered non-sick controls, different controls with possibly frustrating conditions (e.g., lung tumor, cigarette smoking, basic non-lung malignancies) Phase II: Sensitivity and specificity of simultaneous SMRP and osteopontin, alone and in mix, in mesothelioma cases and asbestos-uncovered controls (speaking to the foreseen essential screening connection) Phase III: Specificity of simultaneous SMRP and osteopontin, alone and in blend, for conceivably puzzling conditions (lung growth, different diseases, cigarette smoking) Phase IV: Anticipatory affectability and specificity of SMRP and osteopontin, alone and in mix, utilizing examples from CARET, PLCO, and Wittenoom (Phase V): Sensitivity and specificity of SMRP and osteopontin in erionite-uncovered people

Slide 3

Power

Slide 4

Analysis Plans—Phase II Concurrent affectability and specificity for the screening setting of observation of asbestos-uncovered people Primary investigation will look at as of now settled cutpoints for SMRP and osteopontin for the individual marker assessments Secondary examinations: ROC bends for individual marker execution Identification of an ideal mix board of SMRP and osteopontin and estimation of the ROC bend for the mix, utilizing preparing and test sets Examination of other potential markers that, utilized as a part of conjunction with SMRP and osteopontin, may enhance the marker\'s execution board, utilizing preparing and test sets Comparison of the execution attributes of serum versus plasma osteopontin

Slide 5

Analysis Plans—Phase III Similar to the investigation arrangement for Phase II, however utilizing the ideal individual cutpoints and marker board distinguished in the auxiliary examinations of Phase II These examinations will concentrate on the markers\' specificity and board to mesothelioma versus the other possibly puzzling conditions analyzed in this stage It is not arranged that this stage would change cutpoints or the marker blend standard, but instead could alter the screening connection in which the marker will be connected. Since the essential at-danger populace (at any rate in this nation) is known, it is critical to enhance the board to that hazard populace; non-specificity to puzzling conditions is prone to influence the decision of further screening exercises that would take after a positive test

Slide 6

Analysis Plans—Phase IV Concurrent affectability and specificity of the markers and marker board created in Phases II-III, in tentatively gathered examples from counteractive action trials where predisposition in the middle of cases and controls is improbable Anticipatory affectability and specificity of the markers and the marker board created in Phases II-III, i.e., affectability and specificity of a marker at time t-s to foresee mesothelioma infection status at time t. These examinations will be performed utilizing GEE to represent intra-singular relationship of marker qualities.

Slide 7

.:ts

Recommended
View more...