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CompletedNCT01715961SARCOPENIEUpdated Oct 5, 2016

Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma

An interventional study of anthropometric measurement in Diffuse Large B Cell Lymphoma and Grade IIIB Follicular Lymphoma, sponsored by Centre Henri Becquerel. Completed at 1 site in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2016-10-05.

Sponsored by Centre Henri Becquerel · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Not applicable
Ages
70 Years and older
Sex
All
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Study 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 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.

02

Conditions studied

  • Diffuse Large B Cell Lymphoma
  • Grade IIIB Follicular Lymphoma

Keywords

  • 70 years old
  • DLBCL
  • Rituximab-CHOP
  • Sarcopenia
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In context

Lymphoma, Large B-Cell, Diffuse

1,432 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 359 are open to participants now.

This study's enrollment of 98 is above the median of 47 across 1,214 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

Centre Henri Becquerel is the lead sponsor of 59 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • No initial CT scan imaging performed more than one month before inclusion
  • Positivity for HCV, HBV and HIV
  • Anthracycline contra-indication
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Other
    anthropometric measurement

    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

    Procedure: anthropometric measurement

Interventions

  • Procedureanthropometric measurement

    To attest the muscular strength: hand grip test, balance test, up and go test

    Also known as: Hand Grip strength test, Timed get up and go test

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What researchers measure

Primary outcomes

  1. progression free survival

    Time frame: at 18 months

Secondary outcomes

  1. progression free survival

    Time frame: at 24 months

  2. rate of over grade 2 toxicities

    Time frame: at the first and second courses of chemotherapy (day 21 and day 42)

  3. determination of both molecular subtypes GCB and ABC

    according DASL technology (c-DNA mediated annealing selection extension and ligation)

    Time frame: at 24 months

07

Study locations

1 site
  • Centre Henri Becquerel
    Rouen, 76000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2012, a primary completion of Dec 2015 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2012
First posted
Oct 29, 2012
Start
Jan 2012
Primary completionActual
Dec 2015
CompletionActual
Aug 2016
Last update
Oct 5, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01715961
Lead sponsor
Centre Henri Becquerel
Responsible party
Sponsor
First posted
Oct 29, 2012
Start date
Jan 2012
Primary completion
Dec 2015
Completion
Aug 2016
Last update
Oct 5, 2016

Study contacts

Fabrice JARDIN, MD;PhD
study director · Centre Henri Becquerel

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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