Diffuse Large B-cell LymphomaPROCESSNCT01202448
Prospective Cohort Study With Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma
A study testing CSF analysis in people with Diffuse Large B-cell Lymphoma, run by Samsung Medical Center at 2 sites in South Korea.
Trial summary
This study is to evaluate the incidence of central nervous system (CNS) relapse or metastasis in patients with diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- CSF analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Aug 2010to Feb 2015
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed patients with diffuse large B cell lymphoma
- > 20 years
- life expectancy more than 6 months
- Written informed consent
Who cannot join
- Refusal to informed consent
- Lymphomas other than diffuse large B cell lymphoma
- Primary CNS lymphoma
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Samsung Medical Center
Seoul, 135710
Asan Medical Center
Seoul
About this study
Official title: Prospective Cohort Study With Risk-adapted Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma
This study is to evaluate the incidence of central nervous system (CNS) relapse or metastasis in patients with diffuse large B-cell lymphoma.
Read the detailed description
We dichotomize patients according to the risk of CNS involvement. Then, we perform CNS evaluation in patients at risk of CNS involvement. We prospectively monitor whether CNS relapse or metastasis occurs in patients with diffuse large B-cell lymphoma
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- CSF analysis
- Keywords
- Diffuse large B cell lymphoma, central nervous system, prognosis
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF analysisProcedure or surgery
Also called Brain MRI
The cerebrospinal fluid will be evaluated via lumbar puncture.
| Study group | Role | What they receive |
|---|---|---|
| DLBCL with risk factor | Active comparator | Patients have any of risk factors for secondary CNS involvement Receives: Procedure: CSF analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNS relapse/involvement
After enrollment, patients will be monitored to check the CNS relapse or involvement
Measured: Up to 2 years after participants are enrolled.
Secondary outcomes (1)
survival
The survival outcome of patients will be monitored.
Measured: Up to 2 years after participants are enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2015
- Study completionFeb 2015
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Yonsei University, National Cancer Center, Korea, Korea Cancer Center Hospital, Korea University
- Responsible party
- Principal investigator, Kim, Seok Jin, Samsung Medical Center
- Investigators
- Cheolwon Suh, MD, PhD, Principal investigator, Consortium for Improving Survival of Lymphoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202448
- Sponsor's protocol ID
- 2010-04-091
- Acronym
- PROCESS
- Status last verified
- Mar 2015
- First submitted
- 8 Sep 2010
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study With Risk-adapted Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT01202448
- Acronym / sponsor ID
- PROCESS / 2010-04-091
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Diffuse large B cell lymphoma, central nervous system, prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Asan Medical Center, Yonsei University, National Cancer Center, Korea, Korea Cancer Center Hospital, Korea University
- Study start
- Aug 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 15 Sep 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.
This study is to evaluate the incidence of central nervous system (CNS) relapse or metastasis in patients with diffuse large B-cell lymphoma.
Detailed description
We dichotomize patients according to the risk of CNS involvement. Then, we perform CNS evaluation in patients at risk of CNS involvement. We prospectively monitor whether CNS relapse or metastasis occurs in patients with diffuse large B-cell lymphoma
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DLBCL with risk factor | Active comparator | Procedure: CSF analysisPatients have any of risk factors for secondary CNS involvement |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed patients with diffuse large B cell lymphoma
- > 20 years
- life expectancy more than 6 months
- Written informed consent
Key exclusion criteria (3 listed)
- Refusal to informed consent
- Lymphomas other than diffuse large B cell lymphoma
- Primary CNS lymphoma
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 |
|---|---|---|
| CSF analysisAlso: Brain MRIThe cerebrospinal fluid will be evaluated via lumbar puncture. | Procedure or surgery | DLBCL with risk factor |
Primary outcome
CNS relapse/involvement
Time frame: Up to 2 years after participants are enrolled.
After enrollment, patients will be monitored to check the CNS relapse or involvement
1 secondary outcome
survival
Time frame: Up to 2 years after participants are enrolled
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 3 Mar 2015.
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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.
Cheolwon Suh, MD, PhD principal investigator
Consortium for Improving Survival of Lymphoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSF analysis in people with Diffuse Large B-cell Lymphoma, run by Samsung Medical Center at 2 sites 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 4 inclusion and 3 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 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
CNS relapse/involvement (time frame: Up to 2 years after participants are enrolled.). 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 3 Mar 2015.