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NCT Number: NCT01715961

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.

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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Henri Becquerel

Rouen, 76000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anthropometric measurement

Procedure

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 outcomes

  1. progression free survival

    Time frame: at 18 months

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study 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

Acronym: SARCOPENIE

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Oct 29, 2012
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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