SCM Muscle as a Marker for Frailty in Patients Undergoing... | NCT06704256

Studies
SCM Muscle as a Marker for Frailty in Patients Undergoing ENT Surgery

NCT06704256

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Recruiting

Last Update Posted

Nov 26, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Frailty

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 28, 2024Actual

Primary Completion Date

Oct 23, 2026Estimated

Completion Date

Oct 23, 2026Estimated

First Submitted Date

Nov 22, 2024

First Submission Date that Met QC Criteria

Nov 22, 2024

First Posted Date

Nov 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2024

Last Update Posted Date

Nov 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mingyang L Gray, Assistant Professor Facial Plastic and Reconstructive Surgery Department of Otolaryngology - Head and Neck Surgery, Icahn School of Medicine at Mount SinaiPrincipal Investigator

Lead Sponsor

Icahn School of Medicine at Mount SinaiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients Undergoing Non-Oncologic and Neck surgery		Non-oncologic patients presenting for head and neck surgery with available neck CT scans.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skeletal muscle size	Skeletal muscle derived measures of size of neck skeletal musculature. No maximum or minimum.	End of study at 6 months
Skeletal muscle density	Skeletal muscle derived measures of density of neck skeletal musculature. No maximum or minimum.	End of study at 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Non-oncologic patients presenting for head and neck surgery with available neck CT scans.

Exclusion Criteria:

Patients undergoing cancer surgery
Patients under18 years of age
Patients without pre-surgical CT-scans of the head and neck

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Non-oncologic patients presenting for head and neck surgery with available neck CT scans

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gabriela Hernandez, MD PhD	Contact	814-769-1104		Gabriela.hernandezmeza@mountsinai.org
Mingyang Gray, MD	Contact			Mgray@nyee.com

Overall Officials

Name	Affiliation	Role
Gabriela Hernandez	Icahn School of Medicine at Mount Sinai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai Hospital	Recruiting	New York	New York	10028	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All of the individual participant data collected during the trial, after deidentification.

Types

Study Protocol

Time Frame

Immediately following publication. No end date.

Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.

Any purpose. Data are available indefinitely at (Link to be included in the URL field below).

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000073496	Frailty

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided