Serum Proteomic Profiling for the Early Diagnosis of Colorectal Cancer

May 22, 2012 updated by: Xu jianmin, Fudan University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

547

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Controls
Healthy volunteers
Other: Serum proteomics
magnetic bead-based fractionation coupled with matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry
Other Names:
  • MB coupled with MALDI-TOF MS
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 Names:
  • MB coupled with MALDI-TOF MS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2010.03-2012.05 (2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2010.03-2012.05 (2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Jianmin Xu, M.D.,Ph.D., Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 17, 2012

First Submitted That Met QC Criteria

May 22, 2012

First Posted (Estimate)

May 24, 2012

Study Record Updates

Last Update Posted (Estimate)

May 24, 2012

Last Update Submitted That Met QC Criteria

May 22, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSCG-001
  • 30973416 (Other Grant/Funding Number: the National Natural Science Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Neoplasms

Clinical Trials on Serum proteomics

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe