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Circulating tumor DNA as biomarker for perihilar cholangiocarcinoma


- candidate number25238
- NTR NumberNTR6068
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-aug-2016
- Secondary IDsProtocol ID: NL58159.018.16 
- Public TitleCirculating tumor DNA as biomarker for perihilar cholangiocarcinoma
- Scientific TitleCirculating tumor DNA as a biomarker in perihilar cholangiocarcinoma: a feasibility study
- ACRONYMTUPAC
- hypothesisWe expect to demonstrate that ctDNA can be reliably detected in patients with perihilar cholangiocarcinoma.
- Healt Condition(s) or Problem(s) studiedCholangiocarcinoma, 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 chemotherapy studies.
-HIV/AIDS/hepatitis C in medical history.
-Not able to give informed consent (language, intellectual capacities, etc.).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 15-sep-2016
- planned closingdate1-okt-2017
- Target number of participants20
- InterventionsNone
- Primary outcomeThe aim of this study is to investigate if ctDNA is detectable in the blood of patients with pathologically proven PHC.
- Secondary outcomeWe 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.
- TimepointsWe hope to have collected the 20 patient samples before May 2017.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Eline Soer
- CONTACT for SCIENTIFIC QUERIESProf. dr. T.M. Gulik, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summaryIn 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)
- RECORD31-aug-2016 - 10-nov-2016


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