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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma

Intervention / Treatment
-----------------
* Procedure: anthropometric measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
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: No initial CT scan imaging performed more than one month before inclusion Positivity for HCV, HBV and HIV Anthracycline contra-indication

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: anthropometric measurement<br>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<br>* To attest the muscular strength: hand grip test, balance test, up and go test<br>* Other names: Timed get up and go test;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | at 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | at 24 months | 
| rate of over grade 2 toxicities |  | 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) | at 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
70 years old, DLBCL, Rituximab-CHOP, Sarcopenia