Serum Proteomic Profiling for the Early Diagnosis of Colorectal Cancer

Overview

No ideal serum biomarker currently exists for the early diagnosis of colorectal cancer (CRC). Therefore, it is urgent that accurate and reliable serum biomarkers be identified.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2012

Detailed Description

Magnetic bead-based fractionation coupled with matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry (MALDI-TOF MS) was used to screen serum samples from CRC patients and healthy controls.

Interventions

  • Other: Serum proteomics
    • magnetic bead-based fractionation coupled with matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry

Arms, Groups and Cohorts

  • Colorectal Cancer Patients
    • Patients with histologically confirmed colorectal cancer
  • Healthy Controls
    • Healthy volunteers

Clinical Trial Outcome Measures

Primary Measures

  • Serum peptide mass fingerprinting (PMF)
    • Time Frame: 2010.03-2012.05 (2 years)
    • Compare PMF of the colorectal caner group and control group, and then build the model to distinguish patients with colorectal cancer and controls

Secondary Measures

  • Expressed peptide peaks
    • Time Frame: 2010.03-2012.05 (2 years)
    • Find differentially expressed peptide peaks from the model and identify some ideal serum biomarkers for the early diagnosis of colorectal cancer

Participating in This Clinical Trial

Patients with colorectal cancer Inclusion criteria

  • histologically confirmed colorectal cancer – aged 18 years or older – have provided written informed consent Exclusion criteria – refusal to participate Healthy controls Inclusion criteria – no cancer history – aged 18 years or older – have provided written informed consent Exclusion criteria – refusal to participate – have first-degree relative with a known history of colorectal cancer

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xu jianmin, Professor of General Surgery – Fudan University
  • Overall Official(s)
    • Jianmin Xu, M.D.,Ph.D., Principal Investigator, Fudan University

References

Villanueva J, Shaffer DR, Philip J, Chaparro CA, Erdjument-Bromage H, Olshen AB, Fleisher M, Lilja H, Brogi E, Boyd J, Sanchez-Carbayo M, Holland EC, Cordon-Cardo C, Scher HI, Tempst P. Differential exoprotease activities confer tumor-specific serum peptidome patterns. J Clin Invest. 2006 Jan;116(1):271-84. doi: 10.1172/JCI26022.

Wulfkuhle JD, Liotta LA, Petricoin EF. Proteomic applications for the early detection of cancer. Nat Rev Cancer. 2003 Apr;3(4):267-75. doi: 10.1038/nrc1043.

Cheng AJ, Chen LC, Chien KY, Chen YJ, Chang JT, Wang HM, Liao CT, Chen IH. Oral cancer plasma tumor marker identified with bead-based affinity-fractionated proteomic technology. Clin Chem. 2005 Dec;51(12):2236-44. doi: 10.1373/clinchem.2005.052324. Epub 2005 Oct 20.

Freed GL, Cazares LH, Fichandler CE, Fuller TW, Sawyer CA, Stack BC Jr, Schraff S, Semmes OJ, Wadsworth JT, Drake RR. Differential capture of serum proteins for expression profiling and biomarker discovery in pre- and posttreatment head and neck cancer samples. Laryngoscope. 2008 Jan;118(1):61-8. doi: 10.1097/MLG.0b013e31814cf389.

Rosenblatt KP, Bryant-Greenwood P, Killian JK, Mehta A, Geho D, Espina V, Petricoin EF 3rd, Liotta LA. Serum proteomics in cancer diagnosis and management. Annu Rev Med. 2004;55:97-112. doi: 10.1146/annurev.med.55.091902.105237.

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