Prostate CancerNCT01672905
PSA Antibody Levels in Samples From Patients With Prostate Cancer Treated on Protocol ECOG-E9802
An observational study of Prostate Cancer, run by Eastern Cooperative Oncology Group.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- laboratory biomarker analysis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2012to 7 Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: Evaluation of PSA Antibody on E9802: Confirmation and Concordance
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- laboratory biomarker analysis
- Keywords
- recurrent prostate cancer, stage I prostate cancer, stage IIA prostate cancer, stage IIB prostate cancer, stage III prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA antibody levels are compared between baseline and follow-up at 12 weeks, as well as 24 weeks, using Wilcoxon signed-rank test
Measured: 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
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study start7 Dec 2012
- Primary completion7 Jan 2013
- Study completion7 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert S. DiPaola, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672905
- Sponsor's protocol ID
- CDR0000738979
- Other IDs
- ECOG-E9802T1
- Status last verified
- May 2017
- First submitted
- 23 Aug 2012
- Last updated
- 17 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PSA Antibody on E9802: Confirmation and Concordance
- ClinicalTrials.gov ID
- NCT01672905
- Acronym / sponsor ID
- CDR0000738979
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer, stage I prostate cancer, stage IIA prostate cancer, stage IIB prostate cancer, stage III prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Dec 2012 (actual)
- Primary completion
- 7 Jan 2013 (actual)
- Study completion
- 7 Jan 2013 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Samples from patients who participated in E9802 and provided samples for research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysis | Other | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S. DiPaola, MD principal investigator
Rutgers Cancer Institute of New Jersey
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Eastern Cooperative Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.