Clinical trial NCT01604798: Serum Proteomic Profiling for the Early Diagnosis of Colorectal Cancer
Official title: Serum Proteomic Profiling for the Early Diagnosis of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: proteomics
serum peptides
colorectal cancer
MALDI-TOF MS
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-05-24
Enrollment: 547
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Serum peptide mass fingerprinting (PMF)
timeFrame: 2010.03-2012.05 (2 years)
Secondary outcomes:
measure: Expressed peptide peaks
timeFrame: 2010.03-2012.05 (2 years)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jianmin Xu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.