LymphomaNCT00898963
Biomarkers in Patients With Stage III or Stage IV Follicular Lymphoma Treated on Clinical Trial E-1496
An observational study of Lymphoma, run by ECOG-ACRIN Cancer Research Group.
Trial summary
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- gene expression analysis, microarray analysis and polymorphism analysis
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2007to 11 Feb 2011
- 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 E1496
DISEASE CHARACTERISTICS:
- Diagnosis of follicular lymphoma
- Stage III or IV disease
- Received cyclophosphamide, vincristine, and prednisone with or without rituximab on clinical trial E-1496
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Identification of Biomarkers in Follicular Lymphoma
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.
PURPOSE: This laboratory study is looking at biomarkers in patients with stage III or stage IV follicular lymphoma treated on clinical trial E-1496.
Read the detailed description
OBJECTIVES:
- Correlate gene expression profiles with progression-free survival (PFS) of patients with stage III or IV follicular lymphoma treated with cyclophosphamide, vincristine, and prednisone with or without rituximab on clinical trial E-1496.
- Determine if immunoglobulin Fc-gamma receptor polymorphisms are predictive of PFS in these patients.
- Assess the significance of the microenvironment by constructing tissue microarrays of follicular lymphoma and immunostaining with relevant biomarkers.
- Correlate relevant biomarkers with clinical features, response, and PFS.
OUTLINE: This is a multicenter study.
Tissue samples are analyzed by gene expression profiling, microarrays to predict gene expression, immunohistochemistry, and immunoglobulin Fc-gamma receptor polymorphism analysis for biological markers.
PROJECTED ACCRUAL: A total of 175 samples will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- gene expression analysis, microarray analysis, polymorphism analysis, diagnostic laboratory biomarker analysis, immunohistochemistry staining method
- Keywords
- stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
microarray analysisGenetic
polymorphism analysisGenetic
diagnostic laboratory biomarker analysisOther
immunologic techniqueOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of gene expression profiles with progression-free survival (PFS)
Measured: 1 month
Prediction of PFS by immunoglobulin Fc-gamma receptor polymorphisms as assessed by immunohistochemistry
Measured: 1 month
Assessment of significance of microenvironment by constructing tissue microarrays and immunostaining with relevant biomarkers
Measured: 1 month
Correlation of relevant biomarkers with clinical features, response, and PFS
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 start18 Apr 2007
- Primary completion11 Feb 2011
- Study completion11 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- 175 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
- Randall D. Gascoyne, MD, Study chair, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898963
- Sponsor's protocol ID
- CDR0000544400
- Other IDs
- ECOG-E1496T1
- Status last verified
- Jul 2020
- First submitted
- 9 May 2009
- Last updated
- 31 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers in Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT00898963
- Acronym / sponsor ID
- CDR0000544400
- Conditions
- Lymphoma
- Keywords
- stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Apr 2007 (actual)
- Primary completion
- 11 Feb 2011 (actual)
- Study completion
- 11 Feb 2011 (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 tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.
PURPOSE: This laboratory study is looking at biomarkers in patients with stage III or stage IV follicular lymphoma treated on clinical trial E-1496.
Detailed description
OBJECTIVES:
- Correlate gene expression profiles with progression-free survival (PFS) of patients with stage III or IV follicular lymphoma treated with cyclophosphamide, vincristine, and prednisone with or without rituximab on clinical trial E-1496.
- Determine if immunoglobulin Fc-gamma receptor polymorphisms are predictive of PFS in these patients.
- Assess the significance of the microenvironment by constructing tissue microarrays of follicular lymphoma and immunostaining with relevant biomarkers.
- Correlate relevant biomarkers with clinical features, response, and PFS.
OUTLINE: This is a multicenter study.
Tissue samples are analyzed by gene expression profiling, microarrays to predict gene expression, immunohistochemistry, and immunoglobulin Fc-gamma receptor polymorphism analysis for biological markers.
PROJECTED ACCRUAL: A total of 175 samples will be accrued for this study.
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 E1496
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 | – |
| microarray analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| diagnostic laboratory biomarker analysis | Other | – |
| immunohistochemistry staining method | Other | – |
| immunologic technique | Other | – |
Primary outcome
Correlation of gene expression profiles with progression-free survival (PFS)
Time frame: 1 month
Prediction of PFS by immunoglobulin Fc-gamma receptor polymorphisms as assessed by immunohistochemistry
Time frame: 1 month
Assessment of significance of microenvironment by constructing tissue microarrays and immunostaining with relevant biomarkers
Time frame: 1 month
Correlation of relevant biomarkers with clinical features, response, and PFS
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 31 Jul 2020.
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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.
Randall D. Gascoyne, MD study chair
British Columbia Cancer Agency
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, 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 31 Jul 2020. 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?
Correlation of gene expression profiles with progression-free survival (PFS) (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 31 Jul 2020.