PSA Antibody Levels in Samples From Patients With Prostate Cancer Treated on Protocol ECOG-E9802
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Primary Completion Date :||January 7, 2013|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|