Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045331
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2002-09-06
Brief Title:
Study in Predicting Outcome of Patients Undergoing Radiation Therapy for Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Are the Proteomic Profiles of Serum and Urine Predictivefor Clinical Outcome After Definitive Radiotherapy for Localized Prostate Cancer A Preliminary Cohort Study
Status:
COMPLETED
Status Verified Date:
2004-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Proteins found in blood and urine samples may help predict outcome and allow doctors to plan more effective treatment
PURPOSE Diagnostic trial to study blood and urine proteins in predicting treatment outcome in patients who are undergoing radiation therapy for prostate cancer
PURPOSE Diagnostic trial to study blood and urine proteins in predicting treatment outcome in patients who are undergoing radiation therapy for prostate cancer
Detailed Description:
OBJECTIVES
Correlate serum and urine protein profiles collected before or after radiotherapy with clinical outcome in patients with prostate cancer
Identify protein profiles that can distinguish between patients with no evidence of disease and those with biochemical andor clinical failure
Determine whether those serum proteomic profiles consistent with failure can be identified at early time points in the course of treatment and follow-up of these patients
OUTLINE Patients are stratified according to clinical outcome prior to radiotherapy vs no evidence of disease vs biochemical failure vs clinical failure vs clinical outcome not yet determined
Urine and blood specimens are collected from patients either before or after definitive radiotherapy Samples are analyzed by surface-enhanced laser desorption and ionization time-of-flight mass spectrometry to develop proteomic patterns
Results of proteomic profiles do not influence patient care
PROJECTED ACCRUAL A total of 150 patients 30 per stratum will be accrued for this study
Correlate serum and urine protein profiles collected before or after radiotherapy with clinical outcome in patients with prostate cancer
Identify protein profiles that can distinguish between patients with no evidence of disease and those with biochemical andor clinical failure
Determine whether those serum proteomic profiles consistent with failure can be identified at early time points in the course of treatment and follow-up of these patients
OUTLINE Patients are stratified according to clinical outcome prior to radiotherapy vs no evidence of disease vs biochemical failure vs clinical failure vs clinical outcome not yet determined
Urine and blood specimens are collected from patients either before or after definitive radiotherapy Samples are analyzed by surface-enhanced laser desorption and ionization time-of-flight mass spectrometry to develop proteomic patterns
Results of proteomic profiles do not influence patient care
PROJECTED ACCRUAL A total of 150 patients 30 per stratum will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-02-C-0226 | None | None | None |