NCT00825110

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

11.7 years

First QC Date

January 16, 2009

Last Update Submit

September 13, 2019

Conditions

Keywords

colorectalcancergene expressionbiomarkergenomic mismatch repair

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

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

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Prof Cunningham, David

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

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

Locations