Colorectal CancerNCT00897754
Gene Expression in Patients With Advanced or Metastatic Colorectal Cancer Receiving Bevacizumab
An observational study of Colorectal Cancer, run by ECOG-ACRIN Cancer Research Group.
Trial summary
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- gene expression analysis, protein expression analysis and reverse transcriptase-polymerase chain reaction
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2007to 1 Feb 2009
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Samples submitted for research from patients participating in E3200
DISEASE CHARACTERISTICS:
- Tumor tissue samples available from patients with advanced or metastatic adenocarcinoma of the colon or rectum
- Receiving bevacizumab on clinical trial E-3200
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Alternative Splice Forms of VEGF in Colorectal Cancer - Possible Value in Anti-VEGF Therapy
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.
PURPOSE: This laboratory study is looking at gene expression in patients with advanced or metastatic colorectal cancer receiving bevacizumab.
Read the detailed description
OBJECTIVES:
- Determine whether the balance of splice form expression alters susceptibility of tumors in vivo to respond to anti-VEGF therapy.
OUTLINE: Tumor tissue samples collected on clinical trial E-3200 are analyzed for laboratory endpoints.
- Conditions
- Colorectal Cancer
- Being tested
- gene expression analysis, protein expression analysis, reverse transcriptase-polymerase chain reaction, immunoenzyme technique, immunohistochemistry staining method
- Keywords
- adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, stage III colon cancer, stage IV colon 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.
gene expression analysisGenetic
protein expression analysisGenetic
reverse transcriptase-polymerase chain reactionGenetic
immunoenzyme techniqueOther
immunologic techniqueOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean scores for VEGFb and pan-VEGF gene expression by IHC
Measured: 1 month
Gene expression as measured by tissue microarrays
Measured: 1 month
Splice form expression as measured by reverse transcriptase-PCR
Measured: 1 month
VEGF165b protein expression as measured by ELISA
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start24 Jul 2007
- Primary completion1 Feb 2009
- Study completion1 Feb 2009
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 ECOG-ACRIN Cancer Research GroupThe 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
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Bates, PhD, Study chair, Bristol Heart Institute at University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897754
- Sponsor's protocol ID
- CDR0000560986
- Other IDs
- ECOG-E3200T2
- Status last verified
- May 2017
- First submitted
- 9 May 2009
- Last updated
- 19 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Splice Forms of VEGF in Colorectal Cancer - Possible Value in Anti-VEGF Therapy
- ClinicalTrials.gov ID
- NCT00897754
- Acronym / sponsor ID
- CDR0000560986
- Conditions
- Colorectal Cancer
- Keywords
- adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, stage III colon cancer, stage IV colon cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Jul 2007 (actual)
- Primary completion
- 1 Feb 2009 (actual)
- Study completion
- 1 Feb 2009 (actual)
- First posted
- 12 May 2009 (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 tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.
PURPOSE: This laboratory study is looking at gene expression in patients with advanced or metastatic colorectal cancer receiving bevacizumab.
Detailed description
OBJECTIVES:
- Determine whether the balance of splice form expression alters susceptibility of tumors in vivo to respond to anti-VEGF therapy.
OUTLINE: Tumor tissue samples collected on clinical trial E-3200 are analyzed for laboratory endpoints.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Samples submitted for research from patients participating in E3200
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 |
|---|---|---|
| gene expression analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| immunoenzyme technique | Other | – |
| immunohistochemistry staining method | Other | – |
| immunologic technique | Other | – |
Primary outcome
Mean scores for VEGFb and pan-VEGF gene expression by IHC
Time frame: 1 month
Gene expression as measured by tissue microarrays
Time frame: 1 month
Splice form expression as measured by reverse transcriptase-PCR
Time frame: 1 month
VEGF165b protein expression as measured by ELISA
Time frame: 1 month
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 19 May 2017.
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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 Bates, PhD study chair
Bristol Heart Institute at University of Bristol
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by ECOG-ACRIN Cancer Research Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 May 2017. 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?
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.
What does the primary outcome measure?
Mean scores for VEGFb and pan-VEGF gene expression by IHC (time frame: 1 month). The study lists 4 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 19 May 2017.