Body Composition Changes During Stem Cell Transplantation: The Case Of Lymphoma Patients

May 9, 2017 updated by: American University of Beirut Medical Center
Skeletal Muscle Index (SMI) and Visceral Adipose Ratio (VAR) assess body composition changes and disclose malnutrition risk effectively. The aims of the study are to assess prevalence of malnutrition in patients planned for SCT, to characterize changes in body composition (SMI, total adipose tissue and VAR) that occur in the peri transplantation phase, and to identify Waist Circumference (WC) cut off points associated with the metabolic syndrome (MetSyn) in patients with B and T cell Lymphoma.

Study Overview

Status

Unknown

Conditions

Detailed Description

This study is a retrospective cohort study of patients having B and T cell lymphoma, who underwent SCT in the Bone Marrow Transplantation (BMT) unit at AUBMC. Consecutive patients having B and T lymphoma who underwent SCT at AUBMC will be identified by the research team and will be included as per the below inclusion and exclusion criteria. Starting from June 2016, patients who meet the inclusion criteria will be included in the study up until June 2006.

The radiologist will access the AUBMC PACS system to review PET/CT scans of the identified patients. SMI, visceral, subcutaneous and intramuscular adipose tissues will be established by assessing at the level of L3.

Study Type

Observational

Enrollment (Anticipated)

105

Contacts and Locations

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

Study Contact

  • Name: Jean El Cheikh, MD
  • Phone Number: 7811 9611350000
  • Email: je46@aub.edu.lb

Study Contact Backup

  • Name: Jana Jabbour, LD, MPH
  • Phone Number: 9611759668
  • Email: jj13@aub.edu.lb

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Recruiting
        • American University of Beirut Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean El Cheikh, MD
        • Sub-Investigator:
          • Jana Jabbour, LD, MPH
        • Sub-Investigator:
          • Batoul Manana, LD
        • Sub-Investigator:
          • Charbel Saadeh, PhD
        • Sub-Investigator:
          • Ali Bazarbachi, MD
        • Sub-Investigator:
          • Didier Blaise, MD
        • Sub-Investigator:
          • Iman Abou Dalle, MD

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

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients having B and T lymphoma who underwent SCT between January 2006 and June 2016 at AUBMC are identified by the research team and are included as per the below inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • Age>16 years
  • Patients having B and T cell lymphoma who have undergone SCT at AUBMC

Exclusion Criteria:

  • Patients with a missing pre-SCT PET/ CT scan
  • Patients with 2 missing post SCT PET / CT scan

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sarcopenia Prevalence
Time Frame: 3 months post Stem Cell Transplantation
3 months post Stem Cell Transplantation
Skeletal Muscle Index Changes
Time Frame: 3 months post Stem Cell Transplantation
3 months post Stem Cell Transplantation

Collaborators and Investigators

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

Sponsor

American University of Beirut Medical Center

Collaborators

Aix Marseille Université

Investigators

  • Principal Investigator: Jean El Cheikh, MD, AUBMC

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 (Actual)

January 1, 2016

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM.J-EC.04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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