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

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ClinicalTrials.gov Identifier: NCT01715961
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel

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.

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Grade IIIB Follicular Lymphoma Procedure: anthropometric measurement Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : August 2016


Arm Intervention/treatment
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
To attest the muscular strength: hand grip test, balance test, up and go test
Other Names:
  • Hand Grip strength test
  • Timed get up and go test



Primary Outcome Measures :
  1. progression free survival [ Time Frame: at 18 months ]

Secondary Outcome Measures :
  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 [ Time Frame: at 24 months ]
    according DASL technology (c-DNA mediated annealing selection extension and ligation)



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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715961


Locations
France
Centre Henri Becquerel
Rouen, France, 76000
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
Study Director: Fabrice JARDIN, MD;PhD Centre Henri Becquerel

Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT01715961     History of Changes
Other Study ID Numbers: CHB 11-02
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Henri Becquerel:
70 years old
DLBCL
Rituximab-CHOP
Sarcopenia

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Sarcopenia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms