NCT00008502

Brief Summary

The purpose of this study is to identify the gene or genes responsible for keloid formation. Keloids are raised scars on the skin that form after a minor injury. A tendency to develop keloids often runs in families, suggesting a possible genetic basis. People who have had a classic (butterfly-shaped or wound-overflowing) keloid for at least one year may be eligible for this study. In addition to these probands (original participants), family members over 12 years of age who have either classic or non-classic keloids and those 18 years of age or older without keloids may participate. Probands and family members with keloids will have a medical history focusing on skin problems-particularly keloids-and a skin examination. In some cases, with the subject s permission, photos of the keloids will be taken. All participants will have 35 milliliters (about 2 tablespoons) of blood drawn for DNA (genetic) testing and for measurement of blood proteins, including cytokines, which can affect other tissues and cause scarring. Part of the blood sample will be used for additional genetic studies unrelated to keloids. The samples will be coded for confidentiality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2001

Completed
7 months until next milestone

Study Start

First participant enrolled

August 14, 2001

Completed
16.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2017

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

16.3 years

First QC Date

January 12, 2001

Last Update Submit

August 26, 2021

Conditions

Keloid

Keywords

GeneticsAfrican AmericansSkinKeloids

Outcome Measures

Primary Outcomes (1)

  • Finding a genetic locus

    The purpose of this study is to identify the gene or genes responsible for keloid formation

    12/01/2018

Study Arms (3)

18 years of age or older

without keloids

family members over 12 years of age

who have either classic or non-classic keloids

Probands

original participants who have had a classic (butterfly-shaped or wound-overflowing) keloidfor at least one year

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People who have had a classic (butterfly-shaped or wound-overflowing) keloid for at least one year may be eligible for this study. In addition to these probands (original participants), family members over 12 years of age who have either classic or non-classic keloids and those 18 years of age or older without keloids may participate.

You may qualify if:

  • Proband: must have a butterfly-shaped or wound-overflowing keloid, present for at least one year (this description represents classic keloid, and avoids hypertrophic scar)
  • Affected family members: all family members of the proband who have either classic keloids, as described above, or non-classic keloids, such as ball shaped-keloids on the ear.
  • Unaffected family members: all family members who lack keloids.
  • Impaired subjects for whom a legal guardian provides consent.
  • Pregnant women.
  • EXCLSUION CIRTERIA:
  • Subjects who are unwilling or unable to give informed consent or assent.
  • Impaired individuals from whom it not possible to obtained parental consent (minors) or guardian consent (adults).
  • Keloid patients who have \<3 relatives with keoids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey B Kopp, M.D.

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2001

First Posted

January 15, 2001

Study Start

August 14, 2001

Primary Completion

November 28, 2017

Study Completion

November 28, 2017

Last Updated

August 27, 2021

Record last verified: 2021-08

Locations

US(1)