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SS-GCC1- Screening Study of Genetic Changes in Colorectal Cancer
This study is currently recruiting participants.
Verified by Royal Marsden NHS Foundation Trust, January 2009
First Received: January 16, 2009   No Changes Posted
Sponsored by: Royal Marsden NHS Foundation Trust
Information provided by: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00825110
  Purpose

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.


Condition
Colorectal Cancer

MedlinePlus related topics: Cancer Colorectal Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: SS-GCC1- Screening Study of Genetic Changes in Colorectal Cancer

Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • 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:
  • Secondary outcome measure is the survival and response to treatment of the identified cases.

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

biospecimen includes formalin-fixed, paraffin embedded tissue, fresh frozen tissue and blood smaples


Estimated Enrollment: 3750
Study Start Date: November 2008
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment
confirmed diagnosis of colorectal carcinoma

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825110

Contacts
Contact: David Cunningham 020 8661 3156 jane.neil@rmh.nhs.uk
Contact: Claire Saffery 020 8661 3637 claire.saffery@rmh.nhs.uk

Locations
United Kingdom, Surrey
Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Prof Cunningham     020 8661 3165     jane.neil@rmh.nhs.uk    
Contact: Claire Saffery     020 86613637     claire.saffery@rmh.nhs.uk    
Principal Investigator: Prof Cunningham            
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Prof Cunningham, David Royal Marsden NHS Foundation Trust
Principal Investigator: Prof Cunningham, David Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Royal Marsden NHS Foundation Trust ( Prof David Cunningham )
Study ID Numbers: CCR3085
Study First Received: January 16, 2009
Last Updated: January 16, 2009
ClinicalTrials.gov Identifier: NCT00825110     History of Changes
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
colorectal
cancer
gene expression
biomarker
genomic mismatch repair

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009