- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00535834
Studying Stored Samples From Patients With Localized Prostate Cancer Treated on Clinical Trial NCI-00-C-0154
Data Analysis for 00-C-0154, A Randomized Phase II Study of a PSA-based Vaccine in Patients With Localized Prostate Cancer Receiving Standard Radiotherapy
RATIONALE: Studying samples of blood in the laboratory from patients before and after treatment may help doctors learn more about the effects of the treatment on cells.
PURPOSE: This clinical trial is studying samples collected from patients with localized prostate cancer who received treatment on clinical trial NCI-00-C-0154.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
Primary
- Evaluate the formation of antibody complexes in serum samples taken before initiation of treatment and after completion of therapy in prostate cancer patients previously enrolled on clinical trial NCI-00-C-0154.
- Evaluate immunologic response.
Secondary
- Clone the underlying tumor antigens discovered through SEREX.
OUTLINE: Samples previously collected on clinical trial NCI-00-C-0154 (whole blood, serum, and peripheral mononuclear blood cells) are analyzed for immunologic responses and evidence of formation of anti-tumor antibodies. Western blot is used to detect any evidence of vaccine-induced autoantibody responses. If there is an indication of response, SEREX is used to clone the underlying antigens.
Studietyp
Inskrivning
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
- Diagnosis of localized adenocarcinoma of the prostate
- Received treatment on clinical trial NCI-00-C-0154
PATIENT CHARACTERISTICS:
- Consented the use of their collected blood cells for future research while enrolled on NCI-00-C-0154
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Studieplan
Hur är studien utformad?
Vad mäter studien?
Primära resultatmått
Resultatmått |
|---|
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Immunologiskt svar
|
|
Incidence of formation of antibody complexes in serum samples taken before initiation of treatment and after completion of therapy by western blot and SEREX
|
Sekundära resultatmått
Resultatmått |
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|
Cloning of any underlying tumor antigens discovered in this process
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: James Gulley, MD, PhD, National Cancer Institute (NCI)
Studieavstämningsdatum
Studera stora datum
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 999907214
- 07-C-N214
- CDR0000565972
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