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SKINCATCH Trial: Skin cancer and tumor health care


- candidate number23837
- NTR NumberNTR5746
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-feb-2016
- Secondary IDsMEC 2015-492
- Public TitleSKINCATCH Trial: Skin cancer and tumor health care
- Scientific TitleSKINCATCH Trial: Skin cancer and tumor health care
- ACRONYMSKINCATCH
- hypothesisIs the quality of care of low risk basal cell carcinomas, measured in the histological completeness of the excision of low risk basal cell carcinomas, by general practitioners not inferior to performed by dermatologists.
- Healt Condition(s) or Problem(s) studiedBasal cell carcinoma, Skin cancer
- Inclusion criteriaPatients with a new non-inflammatory skin tumor
- Exclusion criteriaPatients younger than 18 years old, Patients with ASA 3, patients unable to understand the study info and materials without an interpreter.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2016
- planned closingdate1-feb-2019
- Target number of participants600
- Interventionsthe intervention arm will receive an intensive training in diagnosing and treating skin tumors
- Primary outcomehistological completeness of the excision of low risk basal cell carcinoma
- Secondary outcomediagnostic accuracy of the diagnosis of the skin tumor cost-effectiveness patient reported outcomes on physician preference, treatment satisfaction and cosmetic outome.
- TimepointsPROMs at t0 and 3 months and 6 months after treatment
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdrs. K.H.R Ramdas
- CONTACT for SCIENTIFIC QUERIESdrs. K.H.R Ramdas
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Stichting Achmea Gezondheidszorg (SAG)
- Publications
- Brief summaryBasal cell carcinoma is the most common type of malignancy with an incidence of 40,000 per year, which is rising every year. Adequate diagnosis and treatment of skin tumors is even more important with a malignancy that puts such a great burden on the health care systems. The government stimulates primary care physicians to perform minor surgery on skin tumors. This study investigates whether the quality of care by general practitioners for low risk basal cell carcinomas is not inferior to the care by dermatologists.
- Main changes (audit trail)
- RECORD5-feb-2016 - 22-mei-2016


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