RECRUITING

Radiotherapy for Keloids

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.

Official Title

Primary Radiotherapy for the Treatment of Keloids: A Pilot Study

Quick Facts

Study Start:2020-12-01

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04722263

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Clinically diagnosed keloid * Surgical excision of keloid is either contraindicated or patient has declined treatment with surgical excision (Note: patients with keloids that recurred after previous resection are eligible, as long as the current keloid is either unresectable or patient has declined resection) * Age ≥ 18 * Study specific informed consent provided	* Prior RT to the area of interest that would result in overlap of radiation therapy fields * Females of child bearing age without a negative serum pregnancy test prior to initiation of RT or unwilling to use contraception prior to and during the radiation course * Keloids in areas where radiation therapy introduces unacceptable high risk of toxicity as determined by the treating radiation oncologist * Uncontrolled intercurrent illness (e.g. symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, or psychiatric situation) that would limit compliance with study requirements as judged by the treatment physicians

Inclusion Criteria

Exclusion Criteria

* Clinically diagnosed keloid
* Surgical excision of keloid is either contraindicated or patient has declined treatment with surgical excision (Note: patients with keloids that recurred after previous resection are eligible, as long as the current keloid is either unresectable or patient has declined resection)
* Age ≥ 18
* Study specific informed consent provided

* Prior RT to the area of interest that would result in overlap of radiation therapy fields
* Females of child bearing age without a negative serum pregnancy test prior to initiation of RT or unwilling to use contraception prior to and during the radiation course
* Keloids in areas where radiation therapy introduces unacceptable high risk of toxicity as determined by the treating radiation oncologist
* Uncontrolled intercurrent illness (e.g. symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, or psychiatric situation) that would limit compliance with study requirements as judged by the treatment physicians

Contacts and Locations

Study Contact

Daniel Alicea

CONTACT

646-538-9909

daniel.alicea2@einsteinmed.edu

Principal Investigator

Keyur J Mehta, MD

PRINCIPAL_INVESTIGATOR

Montefiore

Study Locations (Sites)

Montefiore Medical Center

Bronx, New York, 10467

United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

Keyur J Mehta, MD, PRINCIPAL_INVESTIGATOR, Montefiore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-01

Study Completion Date2026-06

Study Record Updates

Study Start Date2020-12-01

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Keloid