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Circulating tumor DNA as a biomarker in perihilar cholangiocarcinoma: a feasibility study

Circulating tumor DNA as a biomarker in perihilar cholangiocarcinoma: a feasibility study - circulating tumor DNA in perihilar cholangiocarcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43203
Enrollment
20
Registered
2016-08-17
Start date
2016-09-29
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

biliary tract cancer perihilar cholangiocarcinoma

Interventions

Biomarker
ctDNA
Perihilar Cholangiocarcinoma

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: -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 outcomes

Primary

MeasureTime frame
-To determine if ctDNA is presentcan be reliably detected in patients with PHC. -If ctDNA is presentdetected, we will assess if the mutational profile of the tumor matches the profile of the ctDNA

Secondary

MeasureTime frame
-To perform a hotspot mutation analysis in patients with pathologically proven PHC

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)