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RecruitingNCT03309722Updated Oct 13, 2017

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

An observational study in Colorectal Cancer, sponsored by University of Southampton. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-13.

Sponsored by University of Southampton · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Colorectal Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • colorectal cancer

Exclusion criteria

Exclusion Criteria:

  • hereditary CRC; tumours with extensive necrosis
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • early stage

    Other: biomarker study

  • advanced

    Other: biomarker study

Interventions

  • Otherbiomarker study
05

What researchers measure

Primary outcomes

  1. overall survival

    Time frame: 5 years

  2. disease free survival

    Time frame: 5 years

  3. local recurrence

    Time frame: 5 years

  4. distant recurrence

    Time frame: 5 years

06

Study locations

1 of 1 sites recruiting
  • University Hospital Southampton
    Southampton, United Kingdom
    Recruiting
07

References and documents

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. PubMed 26716418 ↗
  • 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. PubMed 25934693 ↗
  • 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. PubMed 25804630 ↗
  • 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. PubMed 25788261 ↗
  • 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. PubMed 24836208 ↗
  • 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. PubMed 23950211 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Icf, Csr

08

Registry details

Key details

Study ID
NCT03309722
Lead sponsor
University of Southampton
Responsible party
Sponsor
First posted
Oct 13, 2017
Start date
Oct 10, 2008
Primary completion
Oct 10, 2020 (estimated)
Completion
Oct 10, 2025 (estimated)
Last update
Oct 13, 2017

Study contacts

Alex Mirnezami, MD PhD
Contact
ahm@soton.ac.uk

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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