LymphomaNCT01563861
S9704-S0014-S0313A Studying Genes in Samples From Patients With Limited or Advanced Diffuse Large B-Cell Lymphoma
An observational study of Lymphoma, run by SWOG Cancer Research Network.
Trial summary
RATIONALE: Studying samples of tumor 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 find better ways to treat cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- RNA analysis, gene expression analysis and immunohistochemistry staining method
- How many people
- 397 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 1997to 31 Oct 2013
- 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: Patients registering to S9704-S0014-S0313 consenting to banking
DISEASE CHARACTERISTICS:
- Diffuse large B-cell lymphoma - Initial diagnostic tissue block, or 4 unstained slides
- Tissue from patients with limited-stage DLBCL enrolled on SWOG trials treated with cyclophosphamide, doxorubicin hydrochloride, prednisone, and vincristine sulfate (CHOP), and monoclonal anti-CD20 antibody backbone
- SWOG-S0014
- SWOG-S0313
- Tissue from patients with advanced-stage DLBCL enrolled on SWOG trials treated with CHOP and monoclonal anti-CD20 antibody backbone
- SWOG-S9704
- SWOG-S0433
- SWOG-S0515
- SWOG-S0806
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Determining the Cell of Origin and Prognostic Gene Signatures in SWOG Trials of Diffuse Large B-Cell Lymphoma
RATIONALE: Studying samples of tumor 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 find better ways to treat cancer.
PURPOSE: This research trial studies genes in samples from patients with limited and advanced diffuse large B-cell lymphoma.
Read the detailed description
OBJECTIVES:
- To determine the proportion of the cell of origin subtypes (germinal center B-cell-like [GCB] vs non-GCB) and expression levels of prognostic genes previously identified in diffuse large B-cell lymphoma (DLBCL) in patient biopsy samples from SWOG trials of limited- and advanced-stage DLBCL, and to assess the association between the results and progression-free survival (PFS).
- To assess the association between these marker results and overall survival (OS).
OUTLINE: Archived formalin-fixed paraffin-embedded tissue are analyzed for gene expression profile by quantitative nuclease protection assay (qNPA) and immunohistochemical analyses. Results are then compared with each patient's progression-free survival and overall survival.
- Conditions
- Lymphoma
- Being tested
- RNA analysis, gene expression analysis, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II 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.
RNA analysisGenetic
gene expression analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of GCB phenotype among limited-stage vs advanced-stage patients
Measured: Retrospectively
Differences in PFS between limited- and advanced-stage patients with the GCB and non-GCB phenotypes
Measured: Retrospectively
Association between GCB markers and OS
Measured: Retrospectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study start15 Sep 1997
- Primary completion1 Jun 2008
- Study completion31 Oct 2013
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 SWOG Cancer Research NetworkThe 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
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Daniel O. Persky, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563861
- Sponsor's protocol ID
- CDR0000729157
- Other IDs
- S9704-S0014-S0313A, U10CA032102
- Status last verified
- Dec 2019
- First submitted
- 23 Mar 2012
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Cell of Origin and Prognostic Gene Signatures in SWOG Trials of Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01563861
- Acronym / sponsor ID
- CDR0000729157
- Conditions
- Lymphoma
- Keywords
- contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II 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
- 397 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Sep 1997 (actual)
- Primary completion
- 1 Jun 2008 (actual)
- Study completion
- 31 Oct 2013 (actual)
- First posted
- 27 Mar 2012 (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 identify and learn more about biomarkers related to cancer. It may also help doctors find better ways to treat cancer.
PURPOSE: This research trial studies genes in samples from patients with limited and advanced diffuse large B-cell lymphoma.
Detailed description
OBJECTIVES:
- To determine the proportion of the cell of origin subtypes (germinal center B-cell-like [GCB] vs non-GCB) and expression levels of prognostic genes previously identified in diffuse large B-cell lymphoma (DLBCL) in patient biopsy samples from SWOG trials of limited- and advanced-stage DLBCL, and to assess the association between the results and progression-free survival (PFS).
- To assess the association between these marker results and overall survival (OS).
OUTLINE: Archived formalin-fixed paraffin-embedded tissue are analyzed for gene expression profile by quantitative nuclease protection assay (qNPA) and immunohistochemical analyses. Results are then compared with each patient's progression-free survival and overall survival.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients registering to S9704-S0014-S0313 consenting to banking
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 |
|---|---|---|
| RNA analysis | Genetic | – |
| gene expression analysis | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Proportion of GCB phenotype among limited-stage vs advanced-stage patients
Time frame: Retrospectively
Differences in PFS between limited- and advanced-stage patients with the GCB and non-GCB phenotypes
Time frame: Retrospectively
Association between GCB markers and OS
Time frame: Retrospectively
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 20 Dec 2019.
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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.
Daniel O. Persky, MD principal investigator
University of Arizona
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by SWOG Cancer Research Network.
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 20 Dec 2019. 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?
Proportion of GCB phenotype among limited-stage vs advanced-stage patients (time frame: Retrospectively). The study lists 3 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 20 Dec 2019.