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

NCT ID: NCT01715961

Last Updated: 2016-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Diffuse Large B Cell Lymphoma Grade IIIB Follicular Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

anthropometric measurement

Intervention Type PROCEDURE

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

Interventions

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anthropometric measurement

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

Intervention Type PROCEDURE

Other Intervention Names

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Hand Grip strength test Timed get up and go test

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Henri Becquerel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrice JARDIN, MD;PhD

Role: STUDY_DIRECTOR

Centre Henri Becquerel

Locations

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Centre Henri Becquerel

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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CHB 11-02

Identifier Type: -

Identifier Source: org_study_id

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