Molecular Pathology of Colorectal Cancer: Investigating the Role of Novel Molecular Profiles, microRNA's, and Their Targets in Colorectal Cancer Progression

Molecular Pathology of Colorectal Cancer: Investigating the Role of Novel Molecular Profiles, microRNA's, and Their Targets in Colorectal Cancer

Molecular pathology of Colorectal Cancer: Investigating the role of novel molecular profiles, microRNA's and their targets in Colorectal Cancer progression

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: biomarker study

Detailed Description

Single centre observational cohort study Prospectively recruited patients biomarker evaluation and identification of novel biomarkers

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Alex Mirnezami, MD PhD; Email: ahm@soton.ac.uk

Study Locations

• United Kingdom
  • Southampton, United Kingdom
    • Recruiting
    • University Hospital Southampton
    • Contact: Nadia Peppa, PhD; Email: ahm@soton.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients with colorectal cancer that consent to study and fit inclusion and exclusion criteria

Description

Inclusion Criteria:

• colorectal cancer

Exclusion Criteria:

• hereditary CRC; tumours with extensive necrosis

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
early stage	Other: biomarker study
advanced	Other: biomarker study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
disease free survival	5 years
overall survival	5 years
local recurrence	5 years
distant recurrence	5 years

Collaborators and Investigators

• Sponsor: University of Southampton

Publications and helpful links

General Publications

• Hanley CJ, Noble F, Ward M, Bullock M, Drifka C, Mellone M, Manousopoulou A, Johnston HE, Hayden A, Thirdborough S, Liu Y, Smith DM, Mellows T, Kao WJ, Garbis SD, Mirnezami A, Underwood TJ, Eliceiri KW, Thomas GJ. A subset of myofibroblastic cancer-associated fibroblasts regulate collagen fiber elongation, which is prognostic in multiple cancers. Oncotarget. 2016 Feb 2;7(5):6159-74. doi: 10.18632/oncotarget.6740.
• Cellura D, Pickard K, Quaratino S, Parker H, Strefford JC, Thomas GJ, Mitter R, Mirnezami AH, Peake NJ. miR-19-Mediated Inhibition of Transglutaminase-2 Leads to Enhanced Invasion and Metastasis in Colorectal Cancer. Mol Cancer Res. 2015 Jul;13(7):1095-1105. doi: 10.1158/1541-7786.MCR-14-0466. Epub 2015 May 1.
• Ling H, Pickard K, Ivan C, Isella C, Ikuo M, Mitter R, Spizzo R, Bullock M, Braicu C, Pileczki V, Vincent K, Pichler M, Stiegelbauer V, Hoefler G, Almeida MI, Hsiao A, Zhang X, Primrose J, Packham G, Liu K, Bojja K, Gafa R, Xiao L, Rossi S, Song JH, Vannini I, Fanini F, Kopetz S, Zweidler-McKay P, Wang X, Ionescu C, Irimie A, Fabbri M, Lanza G, Hamilton SR, Berindan-Neagoe I, Medico E, Mirnezami A, Calin GA, Nicoloso MS. The clinical and biological significance of MIR-224 expression in colorectal cancer metastasis. Gut. 2016 Jun;65(6):977-989. doi: 10.1136/gutjnl-2015-309372. Epub 2015 Mar 24.
• Bullock MD, Pickard K, Mitter R, Sayan AE, Primrose JN, Ivan C, Calin GA, Thomas GJ, Packham GK, Mirnezami AH. Stratifying risk of recurrence in stage II colorectal cancer using deregulated stromal and epithelial microRNAs. Oncotarget. 2015 Mar 30;6(9):7262-79. doi: 10.18632/oncotarget.3225.
• Bullock MD, Mellone M, Pickard KM, Sayan AE, Mitter R, Primrose JN, Packham GK, Thomas G, Mirnezami AH. Molecular profiling of the invasive tumor microenvironment in a 3-dimensional model of colorectal cancer cells and ex vivo fibroblasts. J Vis Exp. 2014 Apr 29;(86):51475. doi: 10.3791/51475.
• Zhang L, Pickard K, Jenei V, Bullock MD, Bruce A, Mitter R, Kelly G, Paraskeva C, Strefford J, Primrose J, Thomas GJ, Packham G, Mirnezami AH. miR-153 supports colorectal cancer progression via pleiotropic effects that enhance invasion and chemotherapeutic resistance. Cancer Res. 2013 Nov 1;73(21):6435-47. doi: 10.1158/0008-5472.CAN-12-3308. Epub 2013 Aug 15.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2008
• Primary Completion (Anticipated): October 10, 2020
• Study Completion (Anticipated): October 10, 2025

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 13, 2017

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: UKCRNID6067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No