LymphomaNCT01131208
Biomarkers in Patients With Diffuse Large B-Cell Lymphoma Treated With Combination Chemotherapy With or Without Rituximab
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 well patients will respond to treatment. Read more about this study
- Who is it for?
- Ages 60 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- gene expression analysis and laboratory biomarker analysis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 21 Apr 2010to 21 Aug 2010
- 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 60 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Samples from patients enrolled on E4402 from whom samples were submitted for research
DISEASE CHARACTERISTICS:
- Diagnosis of diffuse large B-cell lymphoma
- Treated with CHOP or R-CHOP on ECOG-E4494
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Gene Expression Profiling Using Paraffin-embedded Tissues and the Nuclease Protection Assay in Diffuse Large B-cell Lymphoma (DLBCL) Treated With CHOP or R-CHOP: An ECOG and SWOG Correlative Study of E4494
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 well patients will respond to treatment.
PURPOSE: This research study is studying biomarkers in patients with diffuse large B-cell lymphoma treated with combination chemotherapy with or without rituximab.
Read the detailed description
OBJECTIVES:
- To identify genes predictive of clinical outcome (failure-free survival and overall survival) among patients with diffuse large B-cell lymphoma treated with CHOP or R-CHOP induction on ECOG-E4494 using the nuclease protection assay for measuring gene expression in paraffin-embedded tissue.
- To identify genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy.
OUTLINE: This is a multicenter study.
Unstained formalin-fixed, paraffin-embedded samples are analyzed for gene expression via nuclease protection assay.
- Conditions
- Lymphoma
- Being tested
- gene expression analysis, laboratory biomarker analysis
- Keywords
- contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, recurrent adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of genes predictive of clinical outcome
Measured: 1 month
Identification of genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy
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 posted26 May 2010 (estimated)
- Study start21 Apr 2010
- Primary completion21 Aug 2010
- Study completion21 Aug 2010
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
- 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
- Jane N. Winter, MD, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131208
- Sponsor's protocol ID
- CDR0000671515
- Other IDs
- ECOG-E4494T2
- Status last verified
- May 2017
- First submitted
- 25 May 2010
- Last updated
- 17 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Profiling Using Paraffin-embedded Tissues and the Nuclease Protection Assay in Diffuse Large B-cell Lymphoma (DLBCL) Treated With CHOP or R-CHOP: An ECOG and SWOG Correlative Study of E4494
- ClinicalTrials.gov ID
- NCT01131208
- Acronym / sponsor ID
- CDR0000671515
- Conditions
- Lymphoma
- Keywords
- contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, recurrent adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
- 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
- 21 Apr 2010 (actual)
- Primary completion
- 21 Aug 2010 (actual)
- Study completion
- 21 Aug 2010 (actual)
- First posted
- 26 May 2010 (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 well patients will respond to treatment.
PURPOSE: This research study is studying biomarkers in patients with diffuse large B-cell lymphoma treated with combination chemotherapy with or without rituximab.
Detailed description
OBJECTIVES:
- To identify genes predictive of clinical outcome (failure-free survival and overall survival) among patients with diffuse large B-cell lymphoma treated with CHOP or R-CHOP induction on ECOG-E4494 using the nuclease protection assay for measuring gene expression in paraffin-embedded tissue.
- To identify genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy.
OUTLINE: This is a multicenter study.
Unstained formalin-fixed, paraffin-embedded samples are analyzed for gene expression via nuclease protection assay.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Samples from patients enrolled on E4402 from whom samples were submitted for research
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 | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Identification of genes predictive of clinical outcome
Time frame: 1 month
Identification of genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy
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 17 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.
Jane N. Winter, MD principal investigator
Robert H. Lurie Cancer Center
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 17 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?
Identification of genes predictive of clinical outcome (time frame: 1 month). 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 17 May 2017.