Skin Biophysical Measures for Assessing Head and Neck Can... | NCT04457375

Studies
Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema

NCT04457375

Sponsor

Nova Southeastern University

Status

Completed

Last Update Posted

Jun 9, 2021Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Lymphedema, Secondary

Interventions

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

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2020Actual

Primary Completion Date

Jan 15, 2021Actual

Completion Date

Jan 15, 2021Actual

First Submitted Date

Jun 30, 2020

First Submission Date that Met QC Criteria

Jun 30, 2020

First Posted Date

Jul 7, 2020Actual

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

Jun 7, 2021

Last Update Posted Date

Jun 9, 2021Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Selected measurements in healthy persons of skin tissue dielectric constant as reference values for subsequent use to evaluate patients with head and neck lymphedema.

Detailed Description

Skin tissue dielectric constant (TDC) measurements will non-invasively be made bilaterally at two neck sites, bilaterally on two forearm sites and one site at the chin sub-mental area.

Measurements are made with subjects fully clothed and seated. Measurements are made in triplicate and averaged at each site. Full measurements take about 5-7 minutest to complete. Data will be analyzed to determine the neck-to-arm ratios and chin-to-arm ratios to establish normal ranges of these parameters for subsequent use as comparisons to evaluate and track changes in patients with head and neck lymphedema.

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

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Adults		Healthy	Diagnostic Test: TDC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TDC	Diagnostic Test	measurements	Healthy Adults

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neck-to-Arm TDC ratio	Neck-to-Arm TDC ratio	one year
Sub-Mental-to-Arm TDC ratio	Sub-Mental-to-Arm TDC ratio	one year

Secondary Outcomes

Measure	Description	Time Frame
Bilateral values and Variability in TDC values	Bilateral values and Variability in TDC values	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy with no current or past skin conditions affecting neck or arms

Exclusion Criteria:

Known to have diabetes of any type.
Having facial or neck hair that prohibits accurate measurements

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

Healthy adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nova Southeastern University		Fort Lauderdale	Florida	33328	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008209	Lymphedema
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D009385	Neoplastic Processes
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided