Keloid Tissue Bank

NCT01425437 | Terminated

• 1 other identifier: Tirgan 11-02
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Much progress in treatment of various tumors has been made in the laboratory and the results have been brought back to the patients, i.e. from bench to bedside. This trial intends to collect samples of keloid tissue from patients and study them in laboratory. Such a research may help us with finding better treatments for keloid.

Conditions

Keloid

Keywords

Keloid

Outcome Measures

Primary Outcomes (1)

• Percentage of cases with a genetic mutations within the study cohort will be measured.

  Prevalence of various biomarkers and/or mutations will be determined and co-related with the clinical presentation of the disease.

  Three years

Study Arms (1)

Patients with keloid

All patients will have a clinical diagnosis of keloid and will consent to participate in this study.

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with a clinical diagnosis of keloid who are 13 years or older.

You may qualify if:

• Patients must have clinically confirmed diagnosis of keloid
• Signed consent form; parent or a legal guardian should consent for children and those under age of 18.
• Have at least one paraffin block of excess keloid tissue that has been removed in the past; or is planned to be removed in future.
• Able and willing to undergo a keloid biopsy (optional)
• Able and willing to undergo biopsy of their normal appearing skin (optional, minimum age 18).

You may not qualify if:

• Individuals who are mentally challenged, who cannot consent to participate in this study.
• Psychological Illness that may result in non-compliance with the procedure and the required follow up.
• Known allergy to lidocaine or other local anesthetics.

Sponsors & Collaborators

• Tirgan, Michael H., M.D.: lead

Study Sites (1)

Michael H. Tirgan, MD

New York, New York, 10023, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sample of keloid tissue and small amount of normal appearing skin from an area that is adjacent to the keloid will be collected from each participant. Each patient may undergo one or more biopsies during the span of this study. Tissue biopsy may be repeated from the same or a different keloid in the same patient. Patients may be re-contacted for additional blood or other tissue samples.

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael H Tirgan, MD

  Keloid Research Foundation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 30, 2011
• Study Start: June 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

US (1)