Colon Reference Set Application: Robert Getzenberg - Johns Hopkins (2008)

Abbreviated Name
Colon Ref Set App: Getzenberg (2008)
Lead Investigator
Getzenberg, RobertJohns Hopkins University
Coordinating Investigator
Feng, Ziding Fred Hutchinson Cancer Center
Involved Investigators

Abstact

No abstract availalbe.

Aims

Aim 1: Characterize the distribution of CCSA-3 and CCSA-4 values in a blinded set of serum samples obtained from patients with colorectal adenocarcinoma, colorectal adenomas, , hyperplastic polyps, inflammatory bowel disease and normal colons. Aim 2: Estimate the ROC curves for discrimination between: patients with colorectal cancer versus others; colorectal cancer or adenoma versus others; colorectal cancer, adenoma, or hyperplastic polyps versus IBD; colorectal cancer, adenoma, or hyperplastic polyps versus IBD or normal.

Analytic Method

1.1   Characterize the distribution of CCSA-3 and CCSA-4 values in a blinded set of serum samples obtained from patients with colorectal adenocarcinoma, colorectal adenomas, hyperplastic polyps, inflammatory bowel disease and normal colons. Both CCSA-3 and CCSA-4 are reported as concentrations on continuous scales. Graphical displays and descriptive statistics will be presented by disease category. If the graphical displays indicate the with-population distributions are significantly, non-Gaussian, the values will be appropriately transformed. Analysis of variance will be used to test the null hypothesis (at a 5% significance level) that the means of the populations are equal. 1.2   Estimate the sensitivity and specificity for discrimination between: 1) patients with colorectal cancer versus adenoma, hyperplastic polyps or IBD; 2) colorectal cancer or adenoma versus hyperplastic polyps or IBD; 3) colorectal cancer, adenoma, or hyperplastic polyps versus IBD; 4) colorectal cancer, adenoma, or hyperplastic polyps versus IBD or normal. For each of the four tests, the sensitivity and specificity will be estimated assuming prevalence of 0.50 and equal false negative and false positive costs. The null hypotheses that sensitivity < 0.75 and specificity < 0.75 will be tested using a one-side exact binomial test at a 5% significance level; rejection of the null hypotheses constitutes an argument for advancing the markers to a full validation study. 1.3   Empirical ROC curves will be plotted for Tests 1-4. Optimal sensitivity and specificity will be estimated depending on assumptions about prevalence and the costs of false positives and negatives. Tests 1, 2 and 3 are of particular interest for clinical management, while Test 4 is more relevant for population screening.

Comments

No Data Received at DMCC

Publications

  • No publications available at this time for this protocol.

Biomarkers

Data Collections

  • No data collections available at this time for this protocol.
 Team Project
Start Date
Oct 6 2008
Estimated Finish Date
Feb 6 2009
Finish Date
Feb 25 2010
Protocol ID
250
Protocol Type
Reference Set
Field of Research
Proteomics
Collaborative Group
G.I. and Other Associated Cancers Research Group
Cancer Types
  • Malignant neoplasm of colon

Associated Forms