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PSA Antibody Levels in Samples From Patients With Prostate Cancer Treated on Protocol ECOG-E9802

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01672905
First Posted: August 27, 2012
Last Update Posted: May 17, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
  Purpose

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 Intervention
Prostate Cancer Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of PSA Antibody on E9802: Confirmation and Concordance

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Actual Study Start Date: December 7, 2012
Study Completion Date: January 7, 2013
Primary Completion Date: January 7, 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To evaluate changes in prostate-specific antigen (PSA) antibody levels over time among patients treated on ECOG-E9802.

Secondary

  • 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples from patients who participated in E9802 and provided samples for research
Criteria

DISEASE CHARACTERISTICS: Samples collected on ECOG-E9802 (A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox/TRICOM with GM-CSF in Patients with PSA Progression after Local Therapy for Prostate Cancer)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Robert S. DiPaola, MD Rutgers Cancer Institute of New Jersey
  More Information

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01672905     History of Changes
Other Study ID Numbers: CDR0000738979
ECOG-E9802T1
First Submitted: August 23, 2012
First Posted: August 27, 2012
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group:
recurrent prostate cancer
stage I prostate cancer
stage IIA prostate cancer
stage IIB prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs