SS-GCC1- Screening Study of Genetic Changes in Colorectal Cancer
1 other identifier
observational
3,750
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 16, 2009
CompletedFirst Posted
Study publicly available on registry
January 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedSeptember 17, 2019
September 1, 2019
11.7 years
January 16, 2009
September 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Secondary outcome measure is the survival and response to treatment of the identified cases.
Study Arms (1)
No treatment
confirmed diagnosis of colorectal carcinoma
Eligibility Criteria
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
You may qualify if:
- adults who have a terminal illness
- and over
- confirmed diagnosis of colorectal carcinoma
- ability to give informed consent
- paraffin embedded histological material available for analysis
You may not qualify if:
- medical or psychiatric conditions
- impairing ability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
Biospecimen
biospecimen includes formalin-fixed, paraffin embedded tissue, fresh frozen tissue and blood smaples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof Cunningham, David
Royal Marsden NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2009
First Posted
January 19, 2009
Study Start
November 1, 2008
Primary Completion
July 1, 2020
Study Completion
July 1, 2021
Last Updated
September 17, 2019
Record last verified: 2019-09