FrailtyNCT06704256
SCM Muscle as a Marker for Frailty in Patients Undergoing ENT Surgery
An observational study of Frailty, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study focuses on evaluating the relationship between physical frailty and measurements of the muscles of the neck in patients undergoing non-cancer Head and Neck surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2024to 23 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Non-oncologic patients presenting for head and neck surgery with available neck CT scans
Who may be able to join
- Non-oncologic patients presenting for head and neck surgery with available neck CT scans.
Who cannot join
- Patients undergoing cancer surgery
- Patients under18 years of age
- Patients without pre-surgical CT-scans of the head and neck
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mingyang Gray, MD contact
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
New York, New York, 10028
Mingyang Gray, MD
About this study
This study focuses on evaluating the relationship between physical frailty and measurements of the muscles of the neck in patients undergoing non-cancer Head and Neck surgery.
- Conditions
- Frailty
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Non-Oncologic and Neck surgery | Non-oncologic patients presenting for head and neck surgery with available neck CT scans. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle size
Skeletal muscle derived measures of size of neck skeletal musculature. No maximum or minimum.
Measured: End of study at 6 months
Skeletal muscle density
Skeletal muscle derived measures of density of neck skeletal musculature. No maximum or minimum.
Measured: End of study at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start28 Oct 2024
- Primary completion23 Oct 2026 (estimated)
- Study completion23 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingyang L Gray, Icahn School of Medicine at Mount Sinai
- Investigators
- Gabriela Hernandez, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704256
- Sponsor's protocol ID
- STUDY-24-00751
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCM Muscle as a Marker for Frailty in Patients Undergoing ENT Surgery
- ClinicalTrials.gov ID
- NCT06704256
- Acronym / sponsor ID
- STUDY-24-00751
- Conditions
- Frailty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 23 Oct 2026 (estimated)
- Study completion
- 23 Oct 2026 (estimated)
- First posted
- 26 Nov 2024 (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.
This study focuses on evaluating the relationship between physical frailty and measurements of the muscles of the neck in patients undergoing non-cancer Head and Neck surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Non-Oncologic and Neck surgery | – | –Non-oncologic patients presenting for head and neck surgery with available neck CT scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Non-oncologic patients presenting for head and neck surgery with available neck CT scans
Key inclusion criteria (1 listed)
- Non-oncologic patients presenting for head and neck surgery with available neck CT scans.
Key exclusion criteria (3 listed)
- Patients undergoing cancer surgery
- Patients under18 years of age
- Patients without pre-surgical CT-scans of the head and neck
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
Skeletal muscle size
Time frame: End of study at 6 months
Skeletal muscle derived measures of size of neck skeletal musculature. No maximum or minimum.
Skeletal muscle density
Time frame: End of study at 6 months
Skeletal muscle derived measures of density of neck skeletal musculature. No maximum or minimum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Mingyang Gray, MD contact
Gabriela Hernandez principal investigator
Icahn School of Medicine at Mount Sinai
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 Frailty, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 26 Nov 2024. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Hernandez, MD PhD (814-769-1104, Gabriela.hernandezmeza@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle size (time frame: End of study at 6 months). 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 26 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.