PSA Antibody Levels in Samples From Patients With Prostate Cancer Treated on Protocol ECOG-E9802
|ClinicalTrials.gov Identifier: NCT01672905|
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : May 17, 2017
RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This clinical trial studies prostate-specific antigen (PSA) antibody levels in samples from patients treated for prostate cancer on trial ECOG-E9802.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Other: laboratory biomarker analysis|
- To evaluate changes in prostate-specific antigen (PSA) antibody levels over time among patients treated on ECOG-E9802.
- To characterize the concordance of PSA antibody assessment between the ECOG Immunology Laboratory and the NCI Immunology Laboratory.
OUTLINE: Previously tested samples are evaluated for changes in PSA antibody levels over time (from baseline to follow-up at 12 and 24 weeks) at the ECOG Immunology Laboratory and the NCI Immunology Laboratory. Results are compared between the laboratories.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Evaluation of PSA Antibody on E9802: Confirmation and Concordance|
|Actual Study Start Date :||December 7, 2012|
|Actual Primary Completion Date :||January 7, 2013|
|Actual Study Completion Date :||January 7, 2013|
- PSA antibody levels are compared between baseline and follow-up at 12 weeks, as well as 24 weeks, using Wilcoxon signed-rank test [ Time Frame: 12 weeks ]
- Concordance of PSA antibody assessment between the ECOG Immunology Laboratory and the NCI Immunology Laboratory; concordance correlation coefficient will be computed [ Time Frame: 12 Weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672905
|Principal Investigator:||Robert S. DiPaola, MD||Rutgers Cancer Institute of New Jersey|