Clinical trial · Observational

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

Evaluation of PSA Antibody on E9802: Confirmation and Concordance

NCT01672905CI-TRIAL-00027639completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
laboratory biomarker analysis	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

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

Secondary outcomes (1)

measure
Concordance of PSA antibody assessment between the ECOG Immunology Laboratory and the NCI Immunology Laboratory; concordance correlation coefficient will be computed
timeFrame
12 Weeks

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.