SarcopeniaNCT04547478
L1 M1 of LDCT for Low Muscle Mass Measurement
An observational study of Sarcopenia, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The first lumbar spine muscle index (L1 MI) on computed tomography (CT) obtained by measuring muscle surface at the first lumbar vertebrae (L1) level is an indicator of total skeletal mass in specific populations. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- low dose chest CT(LDCT)
- How many people
- 3,304 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Jan 2019to 10 Jul 2020
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: subjects in routine health assessments
Who may be able to join
- Adults older than 20 years who received LDCT in routine health assessments from January to December 2017 were enrolled at a tertiary care hospital (Far Eastern Memorial Hospital, New Taipei City, Taiwan).
Who cannot join
- nil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Low Muscle Mass by Muscle Surface Index of First Lumbar Vertebrae Using Low Dose Computed Tomography
The first lumbar spine muscle index (L1 MI) on computed tomography (CT) obtained by measuring muscle surface at the first lumbar vertebrae (L1) level is an indicator of total skeletal mass in specific populations. Nevertheless, the utility of L1 MI derived from low dose chest CT (LDCT) in health assessments and relevant cutoff points are unclear.
- Conditions
- Sarcopenia
- Being tested
- low dose chest CT(LDCT)
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose chest CT(LDCT)Diagnostic test
cross sectioned muscle area of the 1st vertebrae level obtained by LDCT
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross sectional muscle area of the 1st vertebrae level
Cross sectional muscle area of the 1st vertebrae level by LDCT
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start21 Jan 2019
- Primary completion20 Apr 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3,304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547478
- Sponsor's protocol ID
- IRB-107091-E
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low Muscle Mass by Muscle Surface Index of First Lumbar Vertebrae Using Low Dose Computed Tomography
- ClinicalTrials.gov ID
- NCT04547478
- Acronym / sponsor ID
- IRB-107091-E
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,304 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 14 Sep 2020 (actual)
- 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.
The first lumbar spine muscle index (L1 MI) on computed tomography (CT) obtained by measuring muscle surface at the first lumbar vertebrae (L1) level is an indicator of total skeletal mass in specific populations. Nevertheless, the utility of L1 MI derived from low dose chest CT (LDCT) in health assessments and relevant cutoff points are unclear.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subjects in routine health assessments
Key inclusion criteria (1 listed)
- Adults older than 20 years who received LDCT in routine health assessments from January to December 2017 were enrolled at a tertiary care hospital (Far Eastern Memorial Hospital, New Taipei City, Taiwan).
Key exclusion criteria (1 listed)
- nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low dose chest CT(LDCT)cross sectioned muscle area of the 1st vertebrae level obtained by LDCT | Diagnostic test | – |
Primary outcome
Cross sectional muscle area of the 1st vertebrae level
Time frame: 52 weeks
Cross sectional muscle area of the 1st vertebrae level by LDCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sarcopenia, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Sep 2020. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross sectional muscle area of the 1st vertebrae level (time frame: 52 weeks). 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 14 Sep 2020.