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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00825110

Enrollment

3750

Registered

2009-01-19

Start date

2008-11-30

Completion date

2021-07-01

Last updated

2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

colorectal, cancer, gene expression, biomarker, genomic mismatch repair

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary outcome measure is the survival and response to treatment of the identified cases.	—

Countries

United Kingdom

Contacts

Primary ContactDavid Cunningham

davidpasutton.cunningham@rmh.nhs.uk020 8661 3156

Backup ContactClaire Saffery

claire.saffery@rmh.nhs.uk020 8661 3637

Outcome results