- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01457079
Keloid Radiation Registry
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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New York
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New York, New York, Forente stater, 10023
- Michael H. Tirgan, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- 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)
Exclusion Criteria:
- None
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Michael H Tirgan, MD, St. Luke's-Roosevelt Hospital Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Tirgan 11-06
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
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Kliniske studier på Keloid
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Queen Mary University of LondonTilbaketrukket
-
SolitonEmergent Clinical Consulting, LLCFullført
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Sensus HealthcareUkjentKeloid arrForente stater
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Sensus HealthcareUkjent
-
University of UlmFullført
-
NYU Langone HealthFullført
-
Northwestern UniversityFullført
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Our Lady of the Lake HospitalLouisiana State University Health Sciences Center in New OrleansFullførtKeloid | Keloid arr etter operasjonForente stater
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National Cheng-Kung University HospitalTainan Hospital, Ministry of Health and WelfareAktiv, ikke rekrutterende
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The University of Western AustraliaAvsluttet