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

• Conditions: Colorectal Cancer

• Registration Number: NCT00825110
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

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.

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-16
• Study First Submitted QC: 2009-01-16
• Study First Posted: 2009-01-19
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-17
• Primary Completion: 2020-07-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3750

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Secondary outcome measure is the survival and response to treatment of the identified cases.

Trial Locations

Locations (1)

Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom