NCT01672905

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

December 7, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2013

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

August 23, 2012

Last Update Submit

May 16, 2017

Conditions

Prostate Cancer

Keywords

recurrent prostate cancerstage I prostate cancerstage IIA prostate cancerstage IIB prostate cancerstage III prostate cancer

Outcome Measures

Primary Outcomes (1)

  • PSA antibody levels are compared between baseline and follow-up at 12 weeks, as well as 24 weeks, using Wilcoxon signed-rank test

    12 weeks

Secondary Outcomes (1)

  • Concordance of PSA antibody assessment between the ECOG Immunology Laboratory and the NCI Immunology Laboratory; concordance correlation coefficient will be computed

    12 Weeks

Interventions

laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples from patients who participated in E9802 and provided samples for research

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Robert S. DiPaola, MD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2012

First Posted

August 27, 2012

Study Start

December 7, 2012

Primary Completion

January 7, 2013

Study Completion

January 7, 2013

Last Updated

May 17, 2017

Record last verified: 2017-05