NCT00427817

Brief Summary

The main objective of this study is to realise serum protein profiles for each patient undergoing a prostate biopsy and to identify relevant proteins.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

2.4 years

First QC Date

January 26, 2007

Last Update Submit

October 5, 2011

Conditions

Adenoma, Prostatic

Keywords

Adenoma, ProstaticProstateProteomicsUrology

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient undergoing a prostate biopsy or a prostatectomy(according to common criteria).

You may qualify if:

  • Patient undergoing a prostate biopsy or a prostatectomy(according to common criteria).

You may not qualify if:

  • Patient refusing to take part in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Department - University Hospital of Grenoble

Grenoble, 38043, France

Location

Related Publications (9)

  • Stattin P, Hakama M. Correspondence re: B-L. Adam et al., Serum protein fingerprinting coupled with a pattern-matching algorithm distinguishes prostate cancer from benign prostate hyperplasia and healthy men. Cancer Res., 62: 3609-3614, 2002. Cancer Res. 2003 May 15;63(10):2701; author reply 2701-2. No abstract available.

    PMID: 12750300BACKGROUND

  • Conrads TP, Fusaro VA, Ross S, Johann D, Rajapakse V, Hitt BA, Steinberg SM, Kohn EC, Fishman DA, Whitely G, Barrett JC, Liotta LA, Petricoin EF 3rd, Veenstra TD. High-resolution serum proteomic features for ovarian cancer detection. Endocr Relat Cancer. 2004 Jun;11(2):163-78. doi: 10.1677/erc.0.0110163.

    PMID: 15163296BACKGROUND

  • Lehrer S, Roboz J, Ding H, Zhao S, Diamond EJ, Holland JF, Stone NN, Droller MJ, Stock RG. Putative protein markers in the sera of men with prostatic neoplasms. BJU Int. 2003 Aug;92(3):223-5. doi: 10.1046/j.1464-410x.2003.04341.x.

    PMID: 12887471BACKGROUND

  • Ornstein DK, Rayford W, Fusaro VA, Conrads TP, Ross SJ, Hitt BA, Wiggins WW, Veenstra TD, Liotta LA, Petricoin EF 3rd. Serum proteomic profiling can discriminate prostate cancer from benign prostates in men with total prostate specific antigen levels between 2.5 and 15.0 ng/ml. J Urol. 2004 Oct;172(4 Pt 1):1302-5. doi: 10.1097/01.ju.0000139572.88463.39.

    PMID: 15371828BACKGROUND

  • Petricoin EF, Ardekani AM, Hitt BA, Levine PJ, Fusaro VA, Steinberg SM, Mills GB, Simone C, Fishman DA, Kohn EC, Liotta LA. Use of proteomic patterns in serum to identify ovarian cancer. Lancet. 2002 Feb 16;359(9306):572-7. doi: 10.1016/S0140-6736(02)07746-2.

    PMID: 11867112BACKGROUND

  • Petricoin EF 3rd, Ornstein DK, Paweletz CP, Ardekani A, Hackett PS, Hitt BA, Velassco A, Trucco C, Wiegand L, Wood K, Simone CB, Levine PJ, Linehan WM, Emmert-Buck MR, Steinberg SM, Kohn EC, Liotta LA. Serum proteomic patterns for detection of prostate cancer. J Natl Cancer Inst. 2002 Oct 16;94(20):1576-8. doi: 10.1093/jnci/94.20.1576.

    PMID: 12381711BACKGROUND

  • Xiao Z, Prieto D, Conrads TP, Veenstra TD, Issaq HJ. Proteomic patterns: their potential for disease diagnosis. Mol Cell Endocrinol. 2005 Jan 31;230(1-2):95-106. doi: 10.1016/j.mce.2004.10.010.

    PMID: 15664456BACKGROUND

  • Ye B, Cramer DW, Skates SJ, Gygi SP, Pratomo V, Fu L, Horick NK, Licklider LJ, Schorge JO, Berkowitz RS, Mok SC. Haptoglobin-alpha subunit as potential serum biomarker in ovarian cancer: identification and characterization using proteomic profiling and mass spectrometry. Clin Cancer Res. 2003 Aug 1;9(8):2904-11.

    PMID: 12912935BACKGROUND

  • Zhang Z, Bast RC Jr, Yu Y, Li J, Sokoll LJ, Rai AJ, Rosenzweig JM, Cameron B, Wang YY, Meng XY, Berchuck A, Van Haaften-Day C, Hacker NF, de Bruijn HW, van der Zee AG, Jacobs IJ, Fung ET, Chan DW. Three biomarkers identified from serum proteomic analysis for the detection of early stage ovarian cancer. Cancer Res. 2004 Aug 15;64(16):5882-90. doi: 10.1158/0008-5472.CAN-04-0746.

    PMID: 15313933BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Jean Luc DESCOTES, MD

    14th floor D, Urology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2007

First Posted

January 29, 2007

Study Start

August 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2011

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

FR(1)