NCT00373035

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
Last Updated

January 19, 2017

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

September 6, 2006

Last Update Submit

January 17, 2017

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Unique proteins or peptides associated with prostate cancer

Interventions

proteomic profilingGENETIC
immunological diagnostic methodOTHER
laboratory biomarker analysisOTHER
mass spectrometryOTHER
biopsyPROCEDURE
ultrasound imagingPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Indication for a transrectal ultrasonography prostatic biopsy (as part of normal patient care) due to elevated prostate-specific antigen, or abnormal digital rectal examination, or surveillance for prostate cancer PATIENT CHARACTERISTICS: * No prior or other concurrent malignancy except for curatively treated basal cell carcinoma of the skin * No serious medical or psychiatric illness that would preclude informed consent * No concurrent acute illness PRIOR CONCURRENT THERAPY: * No participation in another clinical trial within the past 30 days * No more than one enrollment into this study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

SurroMed Incorporated

Menlo Park, California, 94025, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Mass SpectrometryBiopsyHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative TechniquesCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Frank M. Torti, MD, MPH

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 7, 2006

Study Start

February 1, 2006

Primary Completion

July 1, 2006

Last Updated

January 19, 2017

Record last verified: 2013-06

Locations

US(2)