SELDI Phase I: Assay Validation-Prostate

Abbreviated Name
SELDI -I
Lead Investigator
Semmes, JohnEastern Virginia Medical School
Coordinating Investigator
Zheng, Yingye Fred Hutchinson Cancer Center
Involved Investigators

Abstract

see objectives

Aims

Specific Aim IA/Phase IA - The EDRN-Prostate-SELDI Investigational Collaboration (EPSIC) will implement a process to synchronize SELDI output at the seven participating institutions using a single source of pooled normal sera (QC). Specific Aim IB/Phase IB - The EPSIC will synchronize SELDI output at the seven participating institutions using prostate cancer/control samples with verified presence of optimized diagnostic peaks. The reproducibility of QSTAR will also be determined using the same samples and compared to that of the PBS-II data. Specific Aim IC/Phase IC - The EPSIC will implement a seven-center collaboration to synchronize SELDI output using a new and expanded cohort of prostate cancer cases and controls obtained from all sites. The reproducibility of QSTAR will also be determined using the same samples and compared to that of the PBS-II data.

Analytic Method

The criteria for agreement among labs is based on the agreement in mass location and agreement in protein intensity. Since the true protein mass is unknown at each protein mass measured from the machine (there is always some measurement error, no matter how small it is), the mass location agreement is determined by the agreement of the locations of peaks between each lab and the reference lab (EVMS) and between each lab and other four labs combined. More specifically, after peak identification and alignment are performed by each lab, the coefficient of variation (CV) and intra-class correlation coefficient (ICC) for peak location measures and for peak intensity measures will be calculated for each peak location. The between-lab variation will be compared to the between-sample variation.

Outcome

see objectives

Publications

Biomarkers

Data Collections

Start Date
Dec 23 2002
Estimated Finish Date
Dec 23 2003
Finish Date
Feb 1 2005
Protocol ID
109
Protocol Type
Validation
Fields of Research
  • Other
Collaborative Group
Prostate and Urologic Cancers Research Group
Cancer Types
  • Malignant neoplasm of prostate
Phased Status
1

Associated Forms