Identification of New Biomarkers for Patients With Cholangiocarcinoma and Gallbladder Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHerlev and Gentofte Hospital
About this trial
No validated biomarkers exist that can identify patients with biliary tract cancer at an early stage or predict treatment outcomes. The objective of the present study is to find diagnostic, prognostic and predictive biomarkers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological or cytological diagnosis of BTC
Patients referred for treatment of BTC
Signed informed consent
Disqualifiers
None
Trial population
The study will include patients with BTC referred for oncological treatment (adjuvant, neoadjuvant, or palliative setting \[any treatment line\]) at the Department of Oncology, Herlev \& Gentofte Hospital, Denmark and patients referred for surgery at Rigshospitalet (Denmark). The two sites are responsible for all treatment of BTC in eastern Denmark, a region with a population of almost 2.7 million.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Diagnostic accuracy (sensitivity and specificity)
Outcome for diagnostic biomarkers. Case-control design.
Time frame
Baseline2
Overall survival (OS)
Outcome for prognostic and predictive biomarkers
Time frame
Baseline to death or lost to follow-up, an average of 1 yearSecondary outcomes
1
Progression free survival (PFS)
Outcome for prognostic and predictive biomarkers
Time frame
Baseline to progression, death or lost to follow-up, an average of 1 year2
Incidence of adverse events
Outcome for prognostic and predictive biomarkers related to treatment toxicity.
Time frame
Baseline to progression, death or lost to follow-up, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov