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

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: Colorectal Cancer

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

Study Locations

• United Kingdom
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Recruiting
      • Royal Marsden NHS Foundation Trust
      • Contact: Prof Cunningham; Phone Number: 020 8661 3165; Email: davidpasutton.cunningham@rmh.nhs.uk
      • Contact: Claire Saffery; Phone Number: 020 86613637; Email: claire.saffery@rmh.nhs.uk
      • Principal Investigator: Prof Cunningham

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: 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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

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

Study record dates

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: cancer; biomarker; colorectal; gene expression; genomic mismatch repair
• 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: CCR3085