Analysis of Videodermatoscopic Parameters of Ocular, Peri... | NCT06714799

Studies
Analysis of Videodermatoscopic Parameters of Ocular, Periocular, Conjunctival and Palpebral Neoformations

NCT06714799

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Recruiting

Last Update Posted

Dec 5, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Ocular Surface Disease

Interventions

Not provided

Countries

Italy

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

Oct 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

Jun 15, 2021Actual

Primary Completion Date

Dec 15, 2026Estimated

Completion Date

Dec 15, 2030Estimated

First Submitted Date

Nov 28, 2024

First Submission Date that Met QC Criteria

Nov 28, 2024

First Posted Date

Dec 4, 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

Dec 3, 2024

Last Update Posted Date

Dec 5, 2024Actual

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

ANALYSIS OF VIDEODERMATOSCOPIC PARAMETERS OF OCULAR, PERIOCULAR, CONJUNCTIVAL AND PALPEBRAL NEOFORMATIONS

Detailed Description

The analysis of videodermatoscopic parameters of ocular, periocular, conjunctival and eyelid neoformations refers to the use of advanced technology that allows us to examine in detail the lesions or neoformations that appear in and around the eye areas. Through videodermatoscopy, we can evaluate characteristics such as size, shape, color and internal structure of these neoformations, to distinguish benign ones from those that may require further diagnostic investigations or treatments.

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

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
features that could indicate their benign or malignant nature	clinical and dermoscopic characteristics of periocular and ocular lesions	from enrollment to the end of 2026

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who had been diagnosed with one of the following conditions in the ocular and periocular region: common melanocytic nevus, melanosis, seborrheic keratosis, viral wart, angioma and angiokeratoma, apocrine hydrocystoma, xanthelasma, steatocystoma, actinic keratosis, basal cell carcinoma, squamous cell carcinoma, melanoma.

Exclusion Criteria:

Patients who presented with one of the following conditions were excluded from the study: concomitant inflammatory processes, including blepharitis, chalazion, pterygium, pinguecula), coexistence of multiple, periocular or ocular lesions, diagnosis of syndromic diseases related to a major risk for cutaneous neoformations.

Accepts Healthy Volunteers

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

patients presented to the Videodermatoscopy Outpatient Clinic of the O.U. Dermatology of the S. Orsola-Malpighi General Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sabina Vaccari, MD	Contact	3403646960		sabina.vaccari@aosp.bo.it

Overall Officials

Name	Affiliation	Role
Sabina Vaccari, MD	IRCCS Azienda Ospedaliero-Universitaria di Bologna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Azienda Ospedaliero-Universitaria di Bologna	Recruiting	Bologna		40138	Italy