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

Primary Purpose

Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

anthropometric measurement

About this trial

This is an interventional diagnostic trial for Diffuse Large B Cell Lymphoma focused on measuring 70 years old, DLBCL, Rituximab-CHOP, Sarcopenia

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Henri Becquerel

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

anthropometric measurement

Arm Description

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

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

progression free survival

rate of over grade 2 toxicities

determination of both molecular subtypes GCB and ABC

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

Full Information

NCT ID

NCT01715961

First Posted

April 11, 2012

Last Updated

October 4, 2016

Sponsor

Centre Henri Becquerel

1. Study Identification

Unique Protocol Identification Number

NCT01715961

Brief Title

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

Acronym

SARCOPENIE

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 Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Henri Becquerel

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma

Keywords

70 years old, DLBCL, Rituximab-CHOP, Sarcopenia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

anthropometric measurement

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

anthropometric measurement

Other Intervention Name(s)

Hand Grip strength test, Timed get up and go test

Intervention Description

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

Primary Outcome Measure Information:

Title

progression free survival

Time Frame

at 18 months

Secondary Outcome Measure Information:

Title

progression free survival

Time Frame

at 24 months

Title

rate of over grade 2 toxicities

Time Frame

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

Title

determination of both molecular subtypes GCB and ABC

Description

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

Time Frame

at 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fabrice JARDIN, MD;PhD

Organizational Affiliation

Centre Henri Becquerel

Official's Role

Study Director

Facility Information:

Facility Name

Centre Henri Becquerel

City

Rouen

ZIP/Postal Code

76000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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