|- candidate number||25238|
|- NTR Number||NTR6068|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-aug-2016|
|- Secondary IDs||Protocol ID: NL58159.018.16 |
|- Public Title||Circulating tumor DNA as biomarker for perihilar cholangiocarcinoma|
|- Scientific Title||Circulating tumor DNA as a biomarker
in perihilar cholangiocarcinoma:
a feasibility study
|- hypothesis||We expect to demonstrate that ctDNA can be reliably detected in patients with perihilar cholangiocarcinoma.|
|- Healt Condition(s) or Problem(s) studied||Cholangiocarcinoma, Circulating tumor cells|
|- Inclusion criteria||-Patients older than 18 years.|
-Undergoing explorative laparotomy, diagnostic laparoscopy or percutaneous biopsy.
-Able to understand the information given and provide written informed consent.
|- Exclusion criteria||-Patients 18 years or younger.|
-Unfit for laparotomy/ diagnostic laparoscopy/ biopsies or blood analyses in palliative
-HIV/AIDS/hepatitis C in medical history.
-Not able to give informed consent (language, intellectual capacities, etc.).
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||15-sep-2016|
|- planned closingdate||1-okt-2017|
|- Target number of participants||20|
|- Primary outcome||The aim of this study is to investigate if ctDNA is detectable in the blood of patients with pathologically proven PHC. |
|- Secondary outcome||We will perform mutation analyses on PHC samples to contribute to the literature on mutational profiles of PHC paving the way for implementation in clinical use.|
|- Timepoints||We hope to have collected the 20 patient samples before May 2017.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Eline Soer|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. T.M. Gulik, van|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||In suspected perihilar cholangiocarcinoma, the current diagnostic options are inadequate. Furthermore, a reliable biomarker that can be used for followup desirable. Circulating tumor DNA is promising in this regard.|
The aim of this project is the detection and analysis of ctDNA in perihilar cholangiocarcinoma patients. A condition for the applicability of ctDNA as a biomarker is that the mutation profiles found in ctDNA and the tumor tissue are identical. For this reason, both tumor tissue and ctDNA will be sequenced.
|- Main changes (audit trail)|
|- RECORD||31-aug-2016 - 10-nov-2016|