Diffuse Large B-cell LymphomaNCT01606605
Treatment Resistance Related With Gene Expression Profile of Diffuse Large B-cell Lymphoma
An observational study of Diffuse Large B-cell Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators perform a retrospective microarray gene expression profiling study of FFPE from a cohort of DLBCL patients with whole genome cDNA mediated Annealing Selection and Ligation (WG-DASL) assay. The investigators also study the pattern of microRNA from patients with diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- How many people
- 350 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Dec 2012
- 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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diffuse large B-cell lymphoma
Who may be able to join
- Patients diagnosed with diffuse large B-cell lymphoma
- Patients with tissue blocks available for study
- Patients with adequate medical records
Who cannot join
- Patients diagnosed with other subtypes of lymphoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of Diffuse Large B-cell Lymphoma: Identification of Factors Associated With Treatment Resistance Via Gene Expression Profile
The investigators perform a retrospective microarray gene expression profiling study of FFPE from a cohort of DLBCL patients with whole genome cDNA mediated Annealing Selection and Ligation (WG-DASL) assay. The investigators also study the pattern of microRNA from patients with diffuse large B-cell lymphoma. The results of gene expression profiles and microRNA is correlated with clinical outcomes of diffuse large B-cell lymphoma.
Read the detailed description
- Whole genome cDNA mediated Annealing Selection and Ligation (WG-DASL) assay
- Diffuse large B-cell lymphoma patients
- Paraffin-embedded tissue
- End points: Progression-free survival, overall survival
- Statistics: Leave one-out method
- Nano string assay for microRNA
- Diffuse large B-cell lymphoma patients
- Paraffin-embedded tissue
- End points: Progression-free survival, overall survival
- Statistics: Leave one-out method
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Lymphoma, Prognosis, Relapse, Gene, microRNA
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diffuse large B-cell lymphoma | Patients diagnosed and treated at the Samsung Medical Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who relapse or progress after 1st line chemotherapy
Measured: two years
Secondary outcomes (1)
Number and type of genes and microRNA which are significantly related with relapse or progression (P < 0.05)
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- Won Seog Kim, MD, PhD, Principal investigator, Samsung Medical Center Cancer Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606605
- Sponsor's protocol ID
- 2010-05-025
- Status last verified
- Jan 2013
- First submitted
- 22 May 2012
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Diffuse Large B-cell Lymphoma: Identification of Factors Associated With Treatment Resistance Via Gene Expression Profile
- ClinicalTrials.gov ID
- NCT01606605
- Acronym / sponsor ID
- 2010-05-025
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Lymphoma, Prognosis, Relapse, Gene, microRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 May 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.
The investigators perform a retrospective microarray gene expression profiling study of FFPE from a cohort of DLBCL patients with whole genome cDNA mediated Annealing Selection and Ligation (WG-DASL) assay. The investigators also study the pattern of microRNA from patients with diffuse large B-cell lymphoma. The results of gene expression profiles and microRNA is correlated with clinical outcomes of diffuse large B-cell lymphoma.
Detailed description
- Whole genome cDNA mediated Annealing Selection and Ligation (WG-DASL) assay
- Diffuse large B-cell lymphoma patients
- Paraffin-embedded tissue
- End points: Progression-free survival, overall survival
- Statistics: Leave one-out method
- Nano string assay for microRNA
- Diffuse large B-cell lymphoma patients
- Paraffin-embedded tissue
- End points: Progression-free survival, overall survival
- Statistics: Leave one-out method
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diffuse large B-cell lymphoma | – | –Patients diagnosed and treated at the Samsung Medical Center |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diffuse large B-cell lymphoma
Key inclusion criteria (3 listed)
- Patients diagnosed with diffuse large B-cell lymphoma
- Patients with tissue blocks available for study
- Patients with adequate medical records
Key exclusion criteria (1 listed)
- Patients diagnosed with other subtypes of lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who relapse or progress after 1st line chemotherapy
Time frame: two years
1 secondary outcome
Number and type of genes and microRNA which are significantly related with relapse or progression (P < 0.05)
Time frame: two years
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 15 Jan 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.
Won Seog Kim, MD, PhD principal investigator
Samsung Medical Center Cancer Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B-cell Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of patients who relapse or progress after 1st line chemotherapy (time frame: two years). 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 15 Jan 2013.