NCT02983643

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 10, 2017

Status Verified

October 1, 2016

Enrollment Period

2.1 years

First QC Date

October 3, 2016

Last Update Submit

May 9, 2017

Conditions

Hematopoietic Stem Cell TransplantationMalnutritionMetabolic Syndrome

Keywords

Skeletal Muscle IndexVisceral Adipose TissueMetabolic Syndrome

Outcome Measures

Primary Outcomes (2)

  • Sarcopenia Prevalence

    3 months post Stem Cell Transplantation

  • Skeletal Muscle Index Changes

    3 months post Stem Cell Transplantation

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

MalnutritionMetabolic Syndrome

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Jean El Cheikh, MD

    AUBMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean El Cheikh, MD

CONTACT

9611350000je46@aub.edu.lb

Jana Jabbour, LD, MPH

CONTACT

9611759668jj13@aub.edu.lb

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2016

First Posted

December 6, 2016

Study Start

January 1, 2016

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

May 10, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Locations

LE(1)