Serum Proteomic Profiling for the Early Diagnosis of Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

Serum Proteomic Profiling for the Early Diagnosis of Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604798
• Other study ID #: ZSCG-001
• Secondary ID: 30973416
• Status: Completed
• Phase: N/A
• First received: May 17, 2012
• Last updated: May 22, 2012
• Start date: January 2007
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Epub 2005 Oct 20. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Wulfkuhle JD, Liotta LA, Petricoin EF. Proteomic applications for the early detection of cancer. Nat Rev Cancer. 2003 Apr;3(4):267-75. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum peptide mass fingerprinting (PMF)	Compare PMF of the colorectal caner group and control group, and then build the model to distinguish patients with colorectal cancer and controls	2010.03-2012.05 (2 years)	No
Secondary	Expressed peptide peaks	Find differentially expressed peptide peaks from the model and identify some ideal serum biomarkers for the early diagnosis of colorectal cancer	2010.03-2012.05 (2 years)	No