ClinicalTrials.gg
RecruitingNCT01619553Updated Apr 15, 2026

Genetic Analysis of Keloids

An observational study in Keloid, sponsored by UConn Health. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by UConn Health · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
7,000
Sex
All
01

Study 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.

Read the detailed description

Keloids are scars that keep growing beyond the border of the original wound. They typically persist for several years, expand for an extensive period of time and are sometimes called benign tumors. Keloids often have a lumpy surface and are often tender, itchy or inflamed around the growing border.

Keloids in most keloid patients do not run in the family. In the inheritable form of keloids it is possible that there is one major gene mutation that puts family members at risk for developing keloids. There may be other variations in the DNA (DNA makes up the chromosomes) that determine whether keloids become large and aggressive or stay small and without many symptoms.

For this study we will:

  • Send out study participation kits and consent by phone
  • Collect a saliva sample from eligible individuals
  • Obtain information regarding the keloids
  • Document keloids with photos
  • If keloid patients undergo keloid surgery we ask to obtain some scar tissue that would otherwise be discarded
  • Isolate DNA from the saliva sample
  • Perform genetic analyses of the DNA with the most up-to-date methods available to identify genetic variations
  • Study in the laboratory why the genetic variations cause keloids
02

Conditions studied

  • Keloid

Keywords

  • keloid
  • fibrosis
  • wound healing
  • scar
03

In context

Keloid

138 studies on the registry are indexed under Keloid; 26 are open to participants now.

This study's planned enrollment of 7,000 is above the median of 100 across 23 observational studies indexed under Keloid.

Browse Keloid studies →

Lead sponsor

UConn Health is the lead sponsor of 187 studies on the registry; 18 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals with diagnosed keloids.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • no keloids;
  • unaffected individuals only as part of a participating keloid family
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
7,000 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • affected

    individuals with keloids

  • unaffected

    unrelated unaffected controls or unaffected family members

06

What researchers measure

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.

    Time frame: at time of identification

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 15140214 ↗
  • 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. PubMed 11708945 ↗
  • 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. PubMed 28905881 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2009, a primary completion of Dec 2030 and a completion of Dec 2030. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2012
First posted
Jun 14, 2012
Start
Apr 2009
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Apr 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01619553
Lead sponsor
UConn Health
Responsible party
Ernst Reichenberger (Associate Professor, UConn Health) — Principal investigator
First posted
Jun 14, 2012
Start date
Apr 2009
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Apr 15, 2026

Study contacts

Ernst Reichenberger, PhD
Contact
reichenberger@uchc.edu
866-512-9897
Ernst Reichenberger, PhD
principal investigator · UConn Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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