NCT01604798

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
547

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
Last Updated

May 24, 2012

Status Verified

May 1, 2012

Enrollment Period

5.3 years

First QC Date

May 17, 2012

Last Update Submit

May 22, 2012

Conditions

Colorectal Neoplasms

Keywords

proteomicsserum peptidescolorectal cancerMALDI-TOF MS

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Expressed peptide peaks

    2010.03-2012.05 (2 years)

Study Arms (2)

Colorectal Cancer Patients

Patients with histologically confirmed colorectal cancer

Other: Serum proteomics

Healthy Controls

Healthy volunteers

Other: Serum proteomics

Interventions

Serum proteomicsOTHER

magnetic bead-based fractionation coupled with matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry

Also known as: MB coupled with MALDI-TOF MS
Colorectal Cancer PatientsHealthy Controls

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • histologically confirmed colorectal cancer
  • aged 18 years or older
  • have provided written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (5)

  • 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.

    PMID: 16395409BACKGROUND

  • 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.

    PMID: 12671665BACKGROUND

  • 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.

    PMID: 16239339BACKGROUND

  • 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.

    PMID: 18043497BACKGROUND

  • 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.

    PMID: 14746511BACKGROUND

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.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jianmin Xu, M.D.,Ph.D.

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of General Surgery

Study Record Dates

First Submitted

May 17, 2012

First Posted

May 24, 2012

Study Start

January 1, 2007

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 24, 2012

Record last verified: 2012-05

Locations

CN(1)