NCT01619553

Brief Summary

Keloids have a strong genetic component. The goal of this study is to identify genes and regulatory elements on chromosomes that are the cause for keloids or contribute to keloid scarring.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress79%
Apr 2009Dec 2030

Study Start

First participant enrolled

April 1, 2009

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
18.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

21.7 years

First QC Date

June 12, 2012

Last Update Submit

April 14, 2026

Conditions

Keywords

keloidfibrosiswound healingscar

Outcome Measures

Primary Outcomes (1)

  • Identification of genetic elements

    The goal is to identify relevant genes or genetic elements that cause the disease or contribute to the disease progression and severity.

    at time of identification

Study Arms (2)

affected

individuals with keloids

unaffected

unrelated unaffected controls or unaffected family members

Eligibility Criteria

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

Individuals with diagnosed keloids.

You may qualify if:

  • keloids;
  • unaffected individuals only if part of a participating keloid family

You may not qualify if:

  • no keloids;
  • unaffected individuals only as part of a participating keloid family

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center (UCHC)

Farmington, Connecticut, 06030-3705, United States

RECRUITING

Related Publications (3)

  • Marneros AG, Norris JE, Watanabe S, Reichenberger E, Olsen BR. Genome scans provide evidence for keloid susceptibility loci on chromosomes 2q23 and 7p11. J Invest Dermatol. 2004 May;122(5):1126-32. doi: 10.1111/j.0022-202X.2004.22327.x.

    PMID: 15140214BACKGROUND
  • Marneros AG, Norris JE, Olsen BR, Reichenberger E. Clinical genetics of familial keloids. Arch Dermatol. 2001 Nov;137(11):1429-34. doi: 10.1001/archderm.137.11.1429.

    PMID: 11708945BACKGROUND
  • Santos-Cortez RLP, Hu Y, Sun F, Benahmed-Miniuk F, Tao J, Kanaujiya JK, Ademola S, Fadiora S, Odesina V, Nickerson DA, Bamshad MJ, Olaitan PB, Oluwatosin OM, Leal SM, Reichenberger EJ. Identification of ASAH1 as a susceptibility gene for familial keloids. Eur J Hum Genet. 2017 Oct;25(10):1155-1161. doi: 10.1038/ejhg.2017.121. Epub 2017 Jul 26.

    PMID: 28905881BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, blood, scar tissue

MeSH Terms

Conditions

KeloidFibrosisCicatrix

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ernst Reichenberger, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ernst Reichenberger, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 14, 2012

Study Start

April 1, 2009

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations