Colorectal CancerNCT00467129
Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer
An observational study of Colorectal Cancer, run by University of Sheffield.
Trial summary
RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- microarray analysis, mutation analysis and polymerase chain reaction
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of metastatic colorectal cancer
- Currently receiving chemotherapy at Weston Park Hospital
PATIENT CHARACTERISTICS:
- Not Specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: The Role of Genetic Factors in Clinical Outcome for Colorectal Cancer
RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment.
PURPOSE: This clinical trial is examining genes that affect disease outcome in patients with metastatic colorectal cancer.
Read the detailed description
OBJECTIVES:
- Collect blood samples for DNA extraction for genetic studies from patients receiving chemotherapy for metastatic colorectal cancer.
- Collect detailed clinical, pathological, and chemotherapy data from these patients.
- Identify genetic factors that relate to treatment response and outcome in these patients.
OUTLINE: Blood samples are collected and relevant genes and regions are amplified by PCR. PCR products are then sequenced or genotyped for known biological markers and single nucleotide polymorphisms. Tumor samples from surplus pathology specimens are analyzed for expression of candidate genes and mutation in the candidate genes.
Clinical and family history data is also collected by questionnaire.
PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- microarray analysis, mutation analysis, polymerase chain reaction, polymorphism analysis, laboratory biomarker analysis
- Keywords
- stage IV colon cancer, stage IV rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microarray analysisGenetic
mutation analysisGenetic
polymerase chain reactionGenetic
polymorphism analysisGenetic
laboratory biomarker analysisOther
questionnaire administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Progressive disease-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startJul 2002
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.
- 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
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Investigators
- Angela Cox, PhD, Study chair, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467129
- Sponsor's protocol ID
- CDR0000540670
- Other IDs
- SHEFF-SSREC01/271, SHEFF-USMS-SSREC01/271, EU-20727
- Status last verified
- May 2007
- First submitted
- 25 Apr 2007
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Genetic Factors in Clinical Outcome for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00467129
- Acronym / sponsor ID
- CDR0000540670
- Conditions
- Colorectal Cancer
- Keywords
- stage IV colon cancer, stage IV rectal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- Jul 2002
- First posted
- 27 Apr 2007 (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.
RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment.
PURPOSE: This clinical trial is examining genes that affect disease outcome in patients with metastatic colorectal cancer.
Detailed description
OBJECTIVES:
- Collect blood samples for DNA extraction for genetic studies from patients receiving chemotherapy for metastatic colorectal cancer.
- Collect detailed clinical, pathological, and chemotherapy data from these patients.
- Identify genetic factors that relate to treatment response and outcome in these patients.
OUTLINE: Blood samples are collected and relevant genes and regions are amplified by PCR. PCR products are then sequenced or genotyped for known biological markers and single nucleotide polymorphisms. Tumor samples from surplus pathology specimens are analyzed for expression of candidate genes and mutation in the candidate genes.
Clinical and family history data is also collected by questionnaire.
PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microarray analysis | Genetic | – |
| mutation analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| questionnaire administration | Other | – |
Primary outcome
Survival
Progressive disease-free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 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.
Angela Cox, PhD study chair
University of Sheffield
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by University of Sheffield.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Survival. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 18 Dec 2013.