|- candidate number||15928|
|- NTR Number||NTR4332|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-dec-2013|
|- Secondary IDs||MEC 2013-183 MEC ErasmusMC|
|- Public Title||De invloed van anti-kanker medicijn geinduceerd hand-voet syndroom of hand-voet huid reactie op papillairlijnen van de vingers en kwaliteit van vingerafdrukkenidentificatie.|
|- Scientific Title||The influence of anticancer drug-induced hand-foot syndrome and hand-foot skin reactions on friction ridges of the fingers and quality of fingerprints and fingerprint identification.|
|- hypothesis||Use of capecitabine, sorafenib and sunitinib may cause HFS or HFSR, which subsequently may lead to the disappearance of fingerprints.|
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||• Patients using anti-cancer drugs (capecitabine, sunitinib, sorafenib) that are known for developing HFS or HFSR;|
• Age ≥ 18 years;
• Written informed consent.
|- Exclusion criteria||• Patients with symptomatic skin disease which affect hand palm and fingertips.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-aug-2013|
|- planned closingdate||1-aug-2014|
|- Target number of participants||100|
|- Interventions||On three time points, at baseline, after 4- 6 weeks and at the end of treatment, fingerprints will be taken by one of the study coordinators by using a digital fingerprint scanner (present at outpatient clinic). A photograph of the hands will also be taken. If possible, fingerprints will also be taken 1 year after start of treatment.|
|- Primary outcome||• To examine whether systemic anti-cancer drug-induced HSF or HFSR leads to changes in or loss of friction ridges.
|- Secondary outcome||• To compare the changes of friction ridges among patients. |
• To determine if the anti-cancer drug- induced HSF or HFSR leads to unidentifiable fingerprints for identification/individualization purposes using digital fingerprint scanners.
• To determine whether the changes in friction ridges, caused by the anti- cancer drugs, are reversible when drug treatment is stopped.
|- Timepoints||On three time points, at baseline, after 4- 6 weeks and at the end of treatment and if possible one year after treatment.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD PhD Ron H.J. Mathijssen|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD Ron H.J. Mathijssen|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Medical Oncology|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Department of Medical Oncology|
|- Publications||van Doorn et al. Capecitabine and the Risk of Fingerprint Loss. JAMA Oncol. 2016 Aug 25 [Epub ahead of print]|
|- Brief summary||Use of capecitabine, sorafenib and sunitinib may cause HFS or HFSR, which subsequently may lead to the disappearance of fingerprints. In this exploratory prospective cohort study, we will examine whether anti-cancer drug-induced HFS or HFSR leads to changes of friction ridges and if these friction ridges changes eventually leads to unusable fingerprints for identification/individualization purposes using digital fingerprint scanners. This is of importance for society as a whole.
|- Main changes (audit trail)|
|- RECORD||23-dec-2013 - 12-okt-2016|