Serum Proteomic Profiling for the Early Diagnosis of Colorectal Cancer - Full Text View

Purpose

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.

Condition	Intervention
Colorectal Neoplasms	Other: Serum proteomics

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Serum Proteomic Profiling for the Early Diagnosis of Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:

Serum peptide mass fingerprinting (PMF) [ Time Frame: 2010.03-2012.05 (2 years) ] [ Designated as safety issue: No ]
Compare PMF of the colorectal caner group and control group, and then build the model to distinguish patients with colorectal cancer and controls

Secondary Outcome Measures:

Expressed peptide peaks [ Time Frame: 2010.03-2012.05 (2 years) ] [ Designated as safety issue: No ]
Find differentially expressed peptide peaks from the model and identify some ideal serum biomarkers for the early diagnosis of colorectal cancer

Biospecimen Retention: Samples Without DNA

All fasting blood samples were prepared without anticoagulant and left to clot at room temperature for 1.5 h. The serum was then isolated by centrifugation at 3000 g for 10 min at room temperature and stored at -80℃. All samples were subjected to one freeze-thaw cycle.

Enrollment:	547
Study Start Date:	January 2007
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Colorectal Cancer Patients Patients with histologically confirmed colorectal cancer	Other: Serum proteomics magnetic bead-based fractionation coupled with matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry Other Name: MB coupled with MALDI-TOF MS
Healthy Controls Healthy volunteers	Other: Serum proteomics magnetic bead-based fractionation coupled with matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry Other Name: MB coupled with MALDI-TOF MS

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

All of the CRC serum samples were obtained from patients with histologically confirmed colorectal cancer in the Department of General Surgery, Zhongshan Hospital, Fudan University, China. The control samples were collected from healthy volunteers.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604798

Locations

China, Shanghai
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China, 200032

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator:

Jianmin Xu, M.D.,Ph.D.

Fudan University

More Information

Publications:

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.

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

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.

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.

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.

Responsible Party:	Xu jianmin, Professor of General Surgery, Fudan University
ClinicalTrials.gov Identifier:	NCT01604798 History of Changes
Other Study ID Numbers:	ZSCG-001, 30973416
Study First Received:	May 17, 2012
Last Updated:	May 22, 2012
Health Authority:	China: National Natural Science Foundation

Keywords provided by Fudan University:

proteomics
serum peptides
colorectal cancer
MALDI-TOF MS

Additional relevant MeSH terms:

Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013