Keloid Radiation Registry

Keloid Clinical Trial

Official title:

Keloid Radiation Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01457079
• Other study ID #: Tirgan 11-06
• Status: Active, not recruiting
• Phase: N/A
• First received: October 19, 2011
• Last updated: October 17, 2016
• Start date: December 2011
• Est. completion date: June 2021

Study information

• Verified date: October 2016
• Source: Tirgan, Michael H., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Radiation therapy has been, and is being used in treatment of patients with keloid. Radiation is typically used as an adjunct to surgery in order to reduce the recurrence rate of keloid.

Radiation therapy is not free of long term side effects. Radiation Therapy is known to cause secondary cancers. The investigators also do not have a good understanding as to how effective radiation therapy is in preventing recurrence of keloid.

Purposes of this study are to determine the long term safety as well as efficacy of radiation therapy when used for treatment of keloid.

Description:

The Keloid-Radiation project is a clinical registry of patients with keloid who have been treated with Radiation Therapy. This registry aims to monitor the at least 1,000 keloid patients who received radiation therapy to their keloid and to collect epidemiological and clinical data about these patients in order to assess the long term safety and effectiveness of radiation therapy.

Radiation is currently being used in the treatment of keloid, thus enabling the epidemiological characteristics of patients, analysis of treatment response, modeling the influence of risk factors on patients´ risk of developing long term complications such as a cancer, as well as the detailed analysis of the dose delivered, equipment used and radiation planning. This study intends to gather data about the long term efficacy and safety of radiation therapy and rate of developing secondary cancers in patients who have received radiation therapy for treatment of their keloid.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Clinically confirmed diagnosis of keloid

2. History of radiation therapy for treatment of keloid

3. All Ages

4. Signed informed consent form ( by parent or legal guardian if patient is under the age of 18)

Exclusion Criteria:

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Keloid

Locations

Country	Name	City	State
United States	Michael H. Tirgan, MD	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Tirgan, Michael H., M.D.

Country where clinical trial is conducted

United States,