NCT03309722

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2008

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

12 years

First QC Date

October 10, 2017

Last Update Submit

October 10, 2017

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

  • overall survival

    5 years

  • disease free survival

    5 years

  • local recurrence

    5 years

  • distant recurrence

    5 years

Study Arms (2)

early stage

Other: biomarker study

advanced

Other: biomarker study

Interventions

biomarker studyOTHER
advancedearly stage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • colorectal cancer

You may not qualify if:

  • hereditary CRC; tumours with extensive necrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Southampton

Southampton, United Kingdom

RECRUITING

Related Publications (6)

  • 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.

    PMID: 26716418BACKGROUND

  • 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.

    PMID: 25934693BACKGROUND

  • 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.

    PMID: 25804630BACKGROUND

  • 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.

    PMID: 25788261BACKGROUND

  • 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.

    PMID: 24836208BACKGROUND

  • 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.

    PMID: 23950211BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Alex Mirnezami, MD PhD

CONTACT

ahm@soton.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2017

First Posted

October 13, 2017

Study Start

October 10, 2008

Primary Completion

October 10, 2020

Study Completion

October 10, 2025

Last Updated

October 13, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR

Locations

GB(1)