LymphomaSMC-LCSNCT00822731
Samsung Medical Center-Lymphoma Cohort Study
A study testing Chemotherapy with or without radiotherapy in people with Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to establish a model which can predict the treatment outcome and the risk of treatment-related morbidity in patients with lymphoma. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Chemotherapy with or without radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 953 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Dec 2011
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who were diagnosed as lymphoma
- Over 15 years old
- Patients who agreed the enrollment of study
- Informed consent for sampling
Who cannot join
- Patients who do not want to join the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Predictive Model for Treatment Outcome and Treatment-related Morbidity in a Prospective Cohort Study of Patients With Lymphoma
The purpose of this study is to establish a model which can predict the treatment outcome and the risk of treatment-related morbidity in patients with lymphoma.
Read the detailed description
Although the cure rate of lymphoma has been increased due to the development of newer effective drugs, a substantial portion of patients is still suffered from relapse. Furthermore, the treatment-related morbidity is another factor which can make the treatment outcome worse in patients with lymphoma, especially elderly patients. Thus, this study is going to assess following factors which amy probably affect the treatment outcome and the risk of treatment-related morbidity.
- Biologic factors associated with the aggressiveness of lymphoma
- molecular markers in serum, cytogenetic markers
- Factors associated with the risk of treatment-related morbidity
- comorbidity, nutrition status, performance status, quality of life at diagnosis
- Conditions
- Lymphoma
- Being tested
- Chemotherapy with or without radiotherapy
- Keywords
- Lymphoma, prognosis, morbidity
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy with or without radiotherapyDrug
Also called Chemotherapy:CHOP, RCHOP, (R)HyperCVAD
Treatment regimen will be determined by the sub-type of lymphoma
| Study group | Role | What they receive |
|---|---|---|
| Lymphoma | Experimental | patients diagnosed as lymphoma Receives: Drug: Chemotherapy with or without radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 5 years
Secondary outcomes (3)
Treatment response
Measured: after completion of primary therapy
Rate of occurrence of toxicity
Measured: 2 years from the start of the 1st therapy
Treatment-related morbidity
Measured: within 60 days from the previous therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 953 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim, Seok Jin, Samsung Medical Center
- Investigators
- Seok Jin Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822731
- Sponsor's protocol ID
- 2008-08-068
- Acronym
- SMC-LCS
- Status last verified
- May 2012
- First submitted
- 30 Dec 2008
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cho I, Lee H, Yoon SE, Ryu KJ, Ko YH, Kim WS, Kim SJ. Serum levels of soluble programmed death-ligand 1 (sPD-L1) in patients with primary central nervous system diffuse large B-cell lymphoma. BMC Cancer. 2020 Feb 13;20(1):120. doi: 10.1186/s12885-020-6612-2.
PubMed 32054467Kim SJ, Hong M, Do IG, Lee SH, Ryu KJ, Yoo HY, Hong JY, Ko YH, Kim WS. Serum survivin and vascular endothelial growth factor in extranodal NK/T-cell lymphoma, nasal type: implications for a potential new prognostic indicator. Haematologica. 2015 Mar;100(3):e106-9. doi: 10.3324/haematol.2014.116087. Epub 2014 Dec 5. No abstract available.
PubMed 25480498Hong JY, Yoon DH, Suh C, Huh J, Do IG, Sohn I, Jo J, Jung SH, Hong ME, Yoon H, Ko YH, Kim SJ, Kim WS. EBV-positive diffuse large B-cell lymphoma in young adults: is this a distinct disease entity? Ann Oncol. 2015 Mar;26(3):548-55. doi: 10.1093/annonc/mdu556. Epub 2014 Dec 4.
PubMed 25475080Jung HA, Park S, Cho JH, Kim S, Ko YH, Kim SJ, Kim WS. Prognostic relevance of pretreatment quality of life in diffuse large B-cell lymphoma patients treated with rituximab-CHOP: results from a prospective cohort study. Ann Hematol. 2012 Nov;91(11):1747-56. doi: 10.1007/s00277-012-1516-0. Epub 2012 Jun 28.
PubMed 22739576
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Predictive Model for Treatment Outcome and Treatment-related Morbidity in a Prospective Cohort Study of Patients With Lymphoma
- ClinicalTrials.gov ID
- NCT00822731
- Acronym / sponsor ID
- SMC-LCS / 2008-08-068
- Conditions
- Lymphoma
- Keywords
- Lymphoma, prognosis, morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 953 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Jan 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.
The purpose of this study is to establish a model which can predict the treatment outcome and the risk of treatment-related morbidity in patients with lymphoma.
Detailed description
Although the cure rate of lymphoma has been increased due to the development of newer effective drugs, a substantial portion of patients is still suffered from relapse. Furthermore, the treatment-related morbidity is another factor which can make the treatment outcome worse in patients with lymphoma, especially elderly patients. Thus, this study is going to assess following factors which amy probably affect the treatment outcome and the risk of treatment-related morbidity.
- Biologic factors associated with the aggressiveness of lymphoma
- molecular markers in serum, cytogenetic markers
- Factors associated with the risk of treatment-related morbidity
- comorbidity, nutrition status, performance status, quality of life at diagnosis
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphoma | Experimental | Drug: Chemotherapy with or without radiotherapypatients diagnosed as lymphoma |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who were diagnosed as lymphoma
- Over 15 years old
- Patients who agreed the enrollment of study
- Informed consent for sampling
Key exclusion criteria (1 listed)
- Patients who do not want to join the study
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 |
|---|---|---|
| Chemotherapy with or without radiotherapyAlso: Chemotherapy:CHOP, RCHOP, (R)HyperCVADTreatment regimen will be determined by the sub-type of lymphoma | Drug | Lymphoma |
Primary outcome
all cause mortality
Time frame: 5 years
3 secondary outcomes
Treatment response
Time frame: after completion of primary therapy
Rate of occurrence of toxicity
Time frame: 2 years from the start of the 1st therapy
Treatment-related morbidity
Time frame: within 60 days from the previous therapy
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 23 May 2012.
- Derived from this study: PubMed 32054467Cho I, Lee H, Yoon SE, Ryu KJ, Ko YH, Kim WS, Kim SJ. Serum levels of soluble programmed death-ligand 1 (sPD-L1) in patients with primary central nervous system diffuse large B-cell lymphoma. BMC Cancer. 2020 Feb 13;20(1):120. doi: 10.1186/s12885-020-6612-2.
- Derived from this study: PubMed 25480498Kim SJ, Hong M, Do IG, Lee SH, Ryu KJ, Yoo HY, Hong JY, Ko YH, Kim WS. Serum survivin and vascular endothelial growth factor in extranodal NK/T-cell lymphoma, nasal type: implications for a potential new prognostic indicator. Haematologica. 2015 Mar;100(3):e106-9. doi: 10.3324/haematol.2014.116087. Epub 2014 Dec 5. No abstract available.
- Derived from this study: PubMed 25475080Hong JY, Yoon DH, Suh C, Huh J, Do IG, Sohn I, Jo J, Jung SH, Hong ME, Yoon H, Ko YH, Kim SJ, Kim WS. EBV-positive diffuse large B-cell lymphoma in young adults: is this a distinct disease entity? Ann Oncol. 2015 Mar;26(3):548-55. doi: 10.1093/annonc/mdu556. Epub 2014 Dec 4.
- Derived from this study: PubMed 22739576Jung HA, Park S, Cho JH, Kim S, Ko YH, Kim SJ, Kim WS. Prognostic relevance of pretreatment quality of life in diffuse large B-cell lymphoma patients treated with rituximab-CHOP: results from a prospective cohort study. Ann Hematol. 2012 Nov;91(11):1747-56. doi: 10.1007/s00277-012-1516-0. Epub 2012 Jun 28.
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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.
Seok Jin Kim, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy with or without radiotherapy in people with 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 4 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 23 May 2012. 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?
all cause mortality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00822731, which also lists 4 linked publications.
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 23 May 2012.