Colorectal CancerNCT00220142
Molecular Markers of Prognosis in Colorectal Cancer Patients
An observational study of Colorectal Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To correlate the molecular profile of a series of defined CRCs with prognosis and toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2003to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The GI unit Royal Marsden Hospital NHS trust (RMHNHST) has co-ordinated and published results from a large multicentre randomised clinical trial of patients with locally advanced CRC (Saini et al. 2003). A total of 716 patients Dukes' B and C CRC operated with curative intent were randomised to receive either bolus or infusional 5FU regimes. Patients treated at the RMHNHST made up the majority of the total sample cohort (n=550). Analysis of results after a median of 19.8 months follow-up showed that infused 5-FU given over 12 weeks resulted in similar survival to bolus 5-FU and FA over a six-month period (log rank p=0.764). There was, however, significantly less toxicity associated with the infusional regime.
Who may be able to join
- All patients participating in the RMHNHST study of infusional versus bolus 5FU (Saini et al. 2003).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
To correlate the molecular profile of a series of defined CRCs with prognosis and toxicity.
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Cunningham, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220142
- Sponsor's protocol ID
- 2348
- Status last verified
- May 2013
- First submitted
- 20 Sep 2005
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Markers of Prognosis in Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT00220142
- Acronym / sponsor ID
- 2348
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2003
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To correlate the molecular profile of a series of defined CRCs with prognosis and toxicity.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The GI unit Royal Marsden Hospital NHS trust (RMHNHST) has co-ordinated and published results from a large multicentre randomised clinical trial of patients with locally advanced CRC (Saini et al. 2003). A total of 716 patients Dukes' B and C CRC operated with curative intent were randomised to receive either bolus or infusional 5FU regimes. Patients treated at the RMHNHST made up the majority of the total sample cohort (n=550). Analysis of results after a median of 19.8 months follow-up showed that infused 5-FU given over 12 weeks resulted in similar survival to bolus 5-FU and FA over a six-month period (log rank p=0.764). There was, however, significantly less toxicity associated with the infusional regime.
Key inclusion criteria (1 listed)
- All patients participating in the RMHNHST study of infusional versus bolus 5FU (Saini et al. 2003).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Cunningham principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.