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NCT02983643 Clinical Trial

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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02983643
Other study ID # IM.J-EC.04
Secondary ID
Status Recruiting
Phase N/A
First received October 3, 2016
Last updated May 9, 2017
Start date January 2016
Est. completion date March 2018

Study information
Verified date October 2016
Source American University of Beirut Medical Center
Contact Jean El Cheikh, MD
Phone 9611350000
Email je46@aub.edu.lb
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 105
Est. completion date March 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Lebanon American University of Beirut Medical Center Beirut

Sponsors (2)
Lead Sponsor Collaborator
American University of Beirut Medical Center Aix Marseille Université

Country where clinical trial is conducted

Lebanon, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sarcopenia Prevalence 3 months post Stem Cell Transplantation
Primary Skeletal Muscle Index Changes 3 months post Stem Cell Transplantation
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