SS-GCC1- Screening Study of Genetic Changes in Colorectal Cancer

September 13, 2019 updated by: Royal Marsden NHS Foundation Trust
the principal research objective is to form a database of tissue samples from patients with colorectal (bowel) cancer. The tissue samples that will be used for this research will have already been taken for diagnostic or therapeutic reasons. We will also be asking for consent for a research blood sample. The database will be used to improve our understanding of the molecular genetics and gene expression patterns in colorectal cancer.

Study Overview

Status

Unknown

Conditions

Detailed Description

All patients at the Royal Marsden with a diagnosis of colorectal cancer will be eligible to enter this study. This will include patients both with early and advanced disease, provided they give informed consent. They will give written consent to participate, to include consent for analysis of existing tumour tissue and consent for collection of demographic and clinicopathological data relating to their case and its future outcome, and consent for a blood sample to be taken for research purposes. Additionally, old samples of material surplus to clinical requirements may be collected without specific consent if there is no possibility that it would affect the patient's interest (eg the patient has died).

Study Type

Observational

Enrollment (Anticipated)

3750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients at the Royal Marsden with a diagnosis of colorectal cancer will be eligible to enter this study.

Adults who have a terminal illness

Description

Inclusion Criteria:

  • adults who have a terminal illness
  • 18 and over
  • confirmed diagnosis of colorectal carcinoma
  • ability to give informed consent
  • paraffin embedded histological material available for analysis

Exclusion Criteria:

  • medical or psychiatric conditions
  • impairing ability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
No treatment
confirmed diagnosis of colorectal carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
the primary endpoint is the identification of cases with evidence of loss of the product of one of the four main MMR genes on tumour histology.

Secondary Outcome Measures

Outcome Measure
Secondary outcome measure is the survival and response to treatment of the identified cases.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Prof Cunningham, David, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

January 16, 2009

First Posted (Estimate)

January 19, 2009

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR3085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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