Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373035
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2006-09-06
Brief Title:
Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Biomarkers of Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 Collecting and storing samples of blood and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer
PURPOSE This laboratory study is looking at biomarkers in patients undergoing transrectal ultrasound prostate biopsy
PURPOSE This laboratory study is looking at biomarkers in patients undergoing transrectal ultrasound prostate biopsy
Detailed Description:
OBJECTIVES
Primary
Identify unique proteins or peptides that are associated with prostate cancer by comparing the proteomic or metabolomic analysis of serum plasma and urine from patients with histological evidence of prostate cancer to those without prostate cancer after transrectal ultrasound prostatic biopsy
Secondary
Collect seminal fluid from a subset of patients to test the hypothesis that the fluid collected from the target organ of injury in prostate cancer will have a higher signal of proteinspeptides that are different from those without cancer and may help guide the identification of these differences in the serum plasma and urine
OUTLINE This is a pilot study
Patients undergo collection of serum plasma and urine for biomarkerlaboratory analysis Samples are examined by proteomicmetabolomic analysis by mass spectrometry and immunoassays Patients then undergo a transrectal ultrasonography prostatic biopsy
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Primary
Identify unique proteins or peptides that are associated with prostate cancer by comparing the proteomic or metabolomic analysis of serum plasma and urine from patients with histological evidence of prostate cancer to those without prostate cancer after transrectal ultrasound prostatic biopsy
Secondary
Collect seminal fluid from a subset of patients to test the hypothesis that the fluid collected from the target organ of injury in prostate cancer will have a higher signal of proteinspeptides that are different from those without cancer and may help guide the identification of these differences in the serum plasma and urine
OUTLINE This is a pilot study
Patients undergo collection of serum plasma and urine for biomarkerlaboratory analysis Samples are examined by proteomicmetabolomic analysis by mass spectrometry and immunoassays Patients then undergo a transrectal ultrasonography prostatic biopsy
PROJECTED ACCRUAL A total of 60 patients 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 |
|---|---|---|---|
| CCCWFU-BG03-628 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000490117 | REGISTRY | None | None |