NCT01457079

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

9 years

First QC Date

October 19, 2011

Last Update Submit

October 17, 2016

Conditions

Keloid

Keywords

KeloidRadiation TherapyHypertrophic Scar

Eligibility Criteria

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

This study intends to enroll all patients who have had, or will be receiving radiation therapy for their keloid(s).

You may qualify if:

  • Clinically confirmed diagnosis of keloid
  • History of radiation therapy for treatment of keloid
  • All Ages
  • Signed informed consent form ( by parent or legal guardian if patient is under the age of 18)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael H. Tirgan, MD

New York, New York, 10023, United States

Location

MeSH Terms

Conditions

KeloidCicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michael H Tirgan, MD

    St. Luke's-Roosevelt Hospital Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 21, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

US(1)