Investigation of Methylation of EGFR in the Response of the Cetuximab in Metastatic Colorectal Cancer Patients

NCT02022995 | Completed

• 1 other identifier: 201310053RIND
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Protein arginine methylation is an important process, which regulates diverse cellular functions including cell proliferation, RNA stability, DNA repair and gene transcription. Based on literature search, protein arginine methyltransferase (PRMT) indeed plays important roles in colon cancer pathophysiology. The PRMT expression level is involved in colon cancer patient's survival and has been suggested to be a prognostic marker in colon cancer patients. Recently, our group found a novel methylation on epidermal growth factor receptor (EGFR), which affected EGFR downstream signaling. investigators further observed the methylation event on EGFR not only regulated tumor growth in mouse xenograft model but also influenced cetuximab response in colon cancer cell lines. To further study the clinical correlation between EGFR methylation and cetuximab response, we propose to detect EGFR methylation level in paraffin embedded tissue samples from colorectal cancer patients with or without cetuximab treatment by IHC staining and analyze its correlation with cetuximab response. This study will provide an insight to the strategy of colorectal cancer therapy.

Conditions

Colon Cancer Adenocarcinoma

Keywords

EGFR; cetuximab; colon cancer

Outcome Measures

Primary Outcomes (1)

• evaluate the overall survival of patients with PRMT (arginine methyltransferase)

  24 months

Secondary Outcomes (1)

• evaluate the disease-free survival of patients with PRMT (arginine methyltransferase)

  24 months

Study Arms (2)

Patients with cetuximab treatment

Patients with cetuximab treatment

Patients without cetuximab treatment

Patients without cetuximab treatment

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age between 20-80 years old Patient had surgery in NTUH

You may qualify if:

• Colon cancer stage IV

You may not qualify if:

• Age under 20 years old and over 80 years old Patient didn't have surgery in NTUH

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Been-Ren Lin

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2013
• First Posted: December 30, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 3, 2016

Record last verified: 2016-08

Locations

TW (1)