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

October 4, 2016 updated by: Centre Henri Becquerel

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76000
        • Centre Henri Becquerel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: at 18 months
at 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: at 24 months
at 24 months
rate of over grade 2 toxicities
Time Frame: at the first and second courses of chemotherapy (day 21 and day 42)
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
according DASL technology (c-DNA mediated annealing selection extension and ligation)
at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Investigators

  • Study Director: Fabrice JARDIN, MD;PhD, Centre Henri Becquerel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (ESTIMATE)

October 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB 11-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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