Web Based Investigation of Natural History of Keloid Diso... | NCT01423981

Studies
Web Based Investigation of Natural History of Keloid Disorder, an Online Survey

NCT01423981

Sponsor

Tirgan, Michael H., M.D.

Status

Recruiting

Last Update Posted

Oct 4, 2016Estimated

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Keloid

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

Oct 2016

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

Nov 2011

Primary Completion Date

Dec 2030Estimated

Completion Date

Jun 2031Estimated

First Submitted Date

Aug 23, 2011

First Submission Date that Met QC Criteria

Aug 24, 2011

First Posted Date

Aug 26, 2011Estimated

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

Oct 3, 2016

Last Update Posted Date

Oct 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This trial intends to gather very basic clinical information about keloid, its patterns of presentation, family history, ethnic background and correlation with the type of keloid, as well as prior treatment results that patients have had received.

Detailed Description

This will be a web based study, whereby patients will have to read and acknowledge the consent form online. Once patients agree and acknowledge the terms of the consent form, they will gain access to the questionnaire pages.

For those who are under age of 18, a parent or a legal guardian must sign the consent form and answer the online questions on behalf of the patient.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with keloid disorder.		All participants have a clinical diagnosis of keloid.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine the prevalence different phenotypes of keloid in participants.	Prevalence of different phenotypes of keloid will be measured in the study population and reported. Prevalence of familial keloid in the study population will also be determined and reported. Data will be analyzed to determine the distribution of keloid among different ethic groups. Data will be analyzed to report the percentage of patients who have had one or more treatments and the percentage of patients who have had successful treatments.	Two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must have clinically confirmed diagnosis of keloid
Adults, age over 18
Parent or legal guardian may participate if patient is under the age of 18
Able and willing to complete a web based survey

Exclusion Criteria:

No one will be excluded from this study as long as the inclusion criteria are met.

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 with keloid disorder.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael H Tirgan, MD	Contact	(212) 874 4200		htirgan@gmail.com

Overall Officials

Name	Affiliation	Role
Michael H Tirgan, MD	Keloid Research Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Michael H. Tirgan, MD	Recruiting	New York	New York	10023	United States

Label	URL
Official Study Website	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All data will be shared and published

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007627	Keloid
D002921	Cicatrix
D017439	Cicatrix, Hypertrophic

Ancestor Terms

ID	Term
D003095	Collagen Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D005355	Fibrosis

Browse Leaves

Not provided

Browse Branches

Not provided