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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00825110
• Other study ID #: CCR3085
• Status: Recruiting
• Start date: November 2008
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2019
• Source: Royal Marsden NHS Foundation Trust
• Contact: David Cunningham
• Phone: 020 8661 3156
• Email: davidpasutton.cunningham[@]rmh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3750
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary outcome measure is the survival and response to treatment of the identified cases.