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Treatment precursor stadia of anal cancer with Efudix-cream in HIV positive homosexual men


- candidate number3862
- NTR NumberNTR1415
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-aug-2008
- Secondary IDsMEC 07/318 TRAIN trial
- Public TitleTreatment precursor stadia of anal cancer with Efudix-cream in HIV positive homosexual men
- Scientific Title5-Fluorouracil for the treatment of anal dysplasia in HIV postive MSM
- ACRONYMpilot TRAIN trial
- hypothesis5-FU cream is a potential treatment option for intra-anal AIN
- Healt Condition(s) or Problem(s) studiedAnal intraepithelial neoplasia, HIV-positive patients, Efudix cream
- Inclusion criteria1. Patient is >18 years of age
2. Patient has a proven HIV infection
3. Patients is MSM
- Exclusion criteria1. History of anal carcinoma
2 .History of chronic bowel disease
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2008
- planned closingdate1-okt-2009
- Target number of participants50
- Interventions5-Fluorouracil cream twice a week intra-analy during 16 weeks
- Primary outcome- Histological resolution of AIN
- Relapse rate at 6 and 12 months
- Secondary outcome- Side effects of treatment
- HPV types and load before and after treatment
- Timepointst = 0 start treatment
t= 16 weeks early evaluation
t = 24 weeks: follow up
t = 48 weeks: follow up
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.M. Prins
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.M. Prins
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam, St. Josef Hospital, Ruhr Universität, Bochum
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), St. Josef Hospital, Ruhr Universitšt, Bochum
- PublicationsN/A
- Brief summaryIn this study we will treat about fourty HIV+ MSM with inra-anal anal intrapithelial neoplasia (AIN) with local Efudix for a period of 16 weeks. Primary endpoint is histological resolution at 16 weeks. Follow up will take place after 6 and 12 months.
- Main changes (audit trail)
- RECORD22-aug-2008 - 6-okt-2008


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