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
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.