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

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ClinicalTrials.gov Identifier: NCT03309722
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
University of Southampton

Tracking Information
First Submitted Date October 10, 2017
First Posted Date October 13, 2017
Last Update Posted Date October 13, 2017
Actual Study Start Date October 10, 2008
Estimated Primary Completion Date October 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 10, 2017)
  • overall survival [ Time Frame: 5 years ]
  • disease free survival [ Time Frame: 5 years ]
  • local recurrence [ Time Frame: 5 years ]
  • distant recurrence [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Pathology of Colorectal Cancer: Investigating the Role of Novel Molecular Profiles, microRNA's, and Their Targets in Colorectal Cancer Progression
Official Title Molecular Pathology of Colorectal Cancer: Investigating the Role of Novel Molecular Profiles, microRNA's, and Their Targets in Colorectal Cancer
Brief Summary Molecular pathology of Colorectal Cancer: Investigating the role of novel molecular profiles, microRNA's and their targets in Colorectal Cancer progression
Detailed Description Single centre observational cohort study Prospectively recruited patients biomarker evaluation and identification of novel biomarkers
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population all patients with colorectal cancer that consent to study and fit inclusion and exclusion criteria
Condition Colorectal Cancer
Intervention Other: biomarker study
Study Groups/Cohorts
  • early stage
    Intervention: Other: biomarker study
  • advanced
    Intervention: Other: biomarker study
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 10, 2017)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 10, 2025
Estimated Primary Completion Date October 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • colorectal cancer

Exclusion Criteria:

  • hereditary CRC; tumours with extensive necrosis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Alex Mirnezami, MD PhD ahm@soton.ac.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03309722
Other Study ID Numbers UKCRNID6067
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Responsible Party University of Southampton
Study Sponsor University of Southampton
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Southampton
Verification Date October 2017