No registrations found.
ID
Source
Brief title
Health condition
Perihilar cholangiocarcinoma/ Perihilair cholangiocarcinoom
Klatskin-tumor
Biomarker
Circulating tumor DNA /Circulerend tumor DNA (ctDNA)
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study objective
We expect to demonstrate that ctDNA can be reliably detected in patients with perihilar cholangiocarcinoma.
Study design
We hope to have collected the 20 patient samples before May 2017.
Intervention
None
Eline Soer
PO Box 22660
Amsterdam 1100 DD
The Netherlands
e.c.soer@amc.uva.nl
Eline Soer
PO Box 22660
Amsterdam 1100 DD
The Netherlands
e.c.soer@amc.uva.nl
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.).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5793 |
| NTR-old | NTR6068 |
| Other | : Protocol ID: NL58159.018.16 |