Serum Proteomic Profiling for the Early Diagnosis of Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xu jianmin, Fudan University
ClinicalTrials.gov Identifier:
NCT01604798
First received: May 17, 2012
Last updated: May 22, 2012
Last verified: May 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 22, 2014