Hematopoietic Stem Cell TransplantationNCT02983643
Body Composition Changes During Stem Cell Transplantation: The Case Of Lymphoma Patients
An observational study of Hematopoietic Stem Cell Transplantation and Malnutrition, run by American University of Beirut Medical Center at 1 site in Lebanon.
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… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Malnutrition, Metabolic Syndrome
- How many people
- 105 participants
- Where
- 1 siteLebanon
- Study dates
- Jan 2016to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Age>16 years
- Patients having B and T cell lymphoma who have undergone SCT at AUBMC
Who cannot join
- Patients with a missing pre-SCT PET/ CT scan
- Patients with 2 missing post SCT PET / CT scan
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut
Jana Jabbour, LD, MPH, +961759668, jj13@aub.edu.lb
Jean El Cheikh, MD, +961350000 ext. 7811, je46@aub.edu.lb
About this study
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.
Read the 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.
- Keywords
- Skeletal Muscle Index, Visceral Adipose Tissue, Metabolic Syndrome
- Medical subject headings
- Malnutrition, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Sarcopenia Prevalence
Measured: 3 months post Stem Cell Transplantation
Skeletal Muscle Index Changes
Measured: 3 months post Stem Cell Transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aix Marseille Université
- Responsible party
- Sponsor
- Investigators
- Jean El Cheikh, MD, Principal investigator, AUBMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983643
- Sponsor's protocol ID
- IM.J-EC.04
- Status last verified
- Oct 2016
- First submitted
- 3 Oct 2016
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition Changes During Stem Cell Transplantation: The Case Of Lymphoma Patients
- ClinicalTrials.gov ID
- NCT02983643
- Acronym / sponsor ID
- IM.J-EC.04
- Keywords
- Skeletal Muscle Index, Visceral Adipose Tissue, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Aix Marseille Université
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age>16 years
- Patients having B and T cell lymphoma who have undergone SCT at AUBMC
Key exclusion criteria (2 listed)
- Patients with a missing pre-SCT PET/ CT scan
- Patients with 2 missing post SCT PET / CT scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sarcopenia Prevalence
Time frame: 3 months post Stem Cell Transplantation
Skeletal Muscle Index Changes
Time frame: 3 months post Stem Cell Transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean El Cheikh, MD principal investigator
AUBMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplantation and Malnutrition, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean El Cheikh, MD (9611350000 ext. 7811, je46@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sarcopenia Prevalence (time frame: 3 months post Stem Cell Transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.