Serum Proteomic Profiling for the Early Diagnosis of Colorectal Cancer

NCT ID: NCT01604798

Last Updated: 2012-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

547 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Colorectal Cancer Patients

Patients with histologically confirmed colorectal cancer

Serum proteomics

Intervention Type OTHER

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

Healthy Controls

Healthy volunteers

Serum proteomics

Intervention Type OTHER

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

Interventions

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Serum proteomics

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

Intervention Type OTHER

Other Intervention Names

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MB coupled with MALDI-TOF MS

Eligibility Criteria

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Inclusion Criteria

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


* no cancer history
* aged 18 years or older
* have provided written informed consent

Exclusion Criteria

* refusal to participate

Healthy controls


* refusal to participate
* have first-degree relative with a known history of colorectal cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xu jianmin

Professor of General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 16395409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12671665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16239339 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18043497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14746511 (View on PubMed)

Other Identifiers

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30973416

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ZSCG-001

Identifier Type: -

Identifier Source: org_study_id

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