Diffuse Large B Cell LymphomaSARCOPENIENCT01715961
Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma
A study testing anthropometric measurement in people with Diffuse Large B Cell Lymphoma and Grade IIIB Follicular Lymphoma, run by Centre Henri Becquerel at 1 site in France.
Trial summary
This clinical trial is a multicentric prospective study to assess the clinical and prognostic value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma
- What is being tested?
- anthropometric measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Aug 2016
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients >= 70 years
- DLBCL, grade IIIB follicular lymphoma or histologically proven transformed low grade lymphoma
- Whatever the IPI score and the performance status
- Treated by Rituximab-CHOP or Rituximab-mini-CHOP
- CT scan imaging performed one month or less before inclusion
- Signed informed consent
Who cannot join
- No initial CT scan imaging performed more than one month before inclusion
- Positivity for HCV, HBV and HIV
- Anthracycline contra-indication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Prospective Study to Assess the Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma
This clinical trial is a multicentric prospective study to assess the clinical and prognostic value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma.
Read the detailed description
Sarcopenia status is assessed by CT scan imaging on the overall survival at 18 months in patients older than 70 years with diffuse large B-cell lymphoma treated by R-CHOP.
- Being tested
- anthropometric measurement
- Keywords
- 70 years old, DLBCL, Rituximab-CHOP, Sarcopenia
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anthropometric measurementProcedure or surgery
Also called Hand Grip strength test, Timed get up and go test
To attest the muscular strength: hand grip test, balance test, up and go test
| Study group | Role | What they receive |
|---|---|---|
| anthropometric measurement | Other | The muscle area assessed by CT scan imaging at a lumbar vertebral landmark (L3) at the time of diagnosis, at the end of treatment, at 12 and 18 months
* anthropometric measures (weight, height, BMI, brachial and calf circumference) and MNA (mini nutritional assessment)
* albuminemia, transthyretin, orosomucoid, CRP
* functional test to attest the muscular strength: hand grip test, unipodal test, up and go test
* hematological and non-hematological chemotherapy toxicities of cycle 1 and cycle 2
* OS and PFS at 18 and 24 months
* GCB and ABC phenotypes determined by immunohistochemistry and transcriptome analysis Receives: Procedure: anthropometric measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: at 18 months
Secondary outcomes (3)
progression free survival
Measured: at 24 months
rate of over grade 2 toxicities
Measured: at the first and second courses of chemotherapy (day 21 and day 42)
determination of both molecular subtypes GCB and ABC
according DASL technology (c-DNA mediated annealing selection extension and ligation)
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionAug 2016
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice JARDIN, MD;PhD, Study director, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715961
- Sponsor's protocol ID
- CHB 11-02
- Acronym
- SARCOPENIE
- Status last verified
- Jul 2016
- First submitted
- 11 Apr 2012
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Prospective Study to Assess the Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT01715961
- Acronym / sponsor ID
- SARCOPENIE / CHB 11-02
- Keywords
- 70 years old, DLBCL, Rituximab-CHOP, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 29 Oct 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.
This clinical trial is a multicentric prospective study to assess the clinical and prognostic value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma.
Detailed description
Sarcopenia status is assessed by CT scan imaging on the overall survival at 18 months in patients older than 70 years with diffuse large B-cell lymphoma treated by R-CHOP.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anthropometric measurement | Other | Procedure: anthropometric measurementThe muscle area assessed by CT scan imaging at a lumbar vertebral landmark (L3) at the time of diagnosis, at the end of treatment, at 12 and 18 months * anthropometric measures (weight, height, BMI, brachial and calf circumference) and MNA (mini nutritional assessment) * albuminemia, transthyretin, orosomucoid, CRP * functional test to attest the muscular strength: hand grip test, unipodal test, up and go test * hematological and non-hematological chemotherapy toxicities of cycle 1 and cycle 2 * OS and PFS at 18 and 24 months * GCB and ABC phenotypes determined by immunohistochemistry and transcriptome analysis |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Patients >= 70 years
- DLBCL, grade IIIB follicular lymphoma or histologically proven transformed low grade lymphoma
- Whatever the IPI score and the performance status
- Treated by Rituximab-CHOP or Rituximab-mini-CHOP
- CT scan imaging performed one month or less before inclusion
Key exclusion criteria (3 listed)
- No initial CT scan imaging performed more than one month before inclusion
- Positivity for HCV, HBV and HIV
- Anthracycline contra-indication
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 |
|---|---|---|
| anthropometric measurementAlso: Hand Grip strength test, Timed get up and go testTo attest the muscular strength: hand grip test, balance test, up and go test | Procedure or surgery | anthropometric measurement |
Primary outcome
progression free survival
Time frame: at 18 months
3 secondary outcomes
progression free survival
Time frame: at 24 months
rate of over grade 2 toxicities
Time frame: at the first and second courses of chemotherapy (day 21 and day 42)
determination of both molecular subtypes GCB and ABC
Time frame: at 24 months
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 5 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Fabrice JARDIN, MD;PhD study director
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anthropometric measurement in people with Diffuse Large B Cell Lymphoma and Grade IIIB Follicular Lymphoma, run by Centre Henri Becquerel at 1 site in France.
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 6 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 5 Oct 2016. 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 France. 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?
progression free survival (time frame: at 18 months). 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 5 Oct 2016.