Identification of New Biomarkers for Patients With Cholangiocarcinoma and Gallbladder Cancer
NCT ID: NCT05184400
Last Updated: 2022-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2015-01-01
2030-12-31
Brief Summary
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Detailed Description
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The objective of the present study is to find diagnostic, prognostic, and predictive biomarkers, which can be used to 1) diagnose BTC early in the disease course with high specificity and sensitivity, 2) improve prognostication, or 3) predict and monitor treatment effectiveness and tolerability for the individual patient.
CHOCA is an observational and translational open cohort study with a prospective collection of biological materials (blood samples and tissue) and clinical data in patients with BTC receiving standard or protocolized treatment. Blood samples (i.e. serum, EDTA plasma and buffy coat, and blood in PAXgeneRNA tubes) are collected from all patients before operation or start of chemotherapy and during treatment with blood sampling before the 2nd cycle of chemotherapy and longitudinally at the time of follow-up CT scan (about every 3 months) until disease progression. Tissue removed during routine diagnostic procedures or treatment will be requisitioned.
The patients are followed until death. The following data are collected: Demographics, disease characteristics, comorbidities and lifestyle factors, routine blood tests (i.e. hematology, creatinine, liver enzymes, bilirubin, carbohydrate antigen 19-9, C-reactive protein); type of operation; types of chemotherapy, reason for termination of therapy; date of disease recurrence in operated patients; date of disease progression for each line of chemotherapy; and date of death. Biomarker analyses will include a range of molecules with different characteristics such as DNA, Single Nucleotide Polymorphism (SNPs), RNA, microRNA, proteins, proteoglycans, and metabolites. Controls will be included from other studies in order to identify potential diagnostic biomarkers,. Controls include patients with other diseases or healthy subjects. Biomarkers will be analyzed using appropriate methods and statistical analysis following REMARK guidelines.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients referred for treatment of BTC
* Signed informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Herlev and Gentofte Hospital
OTHER
Responsible Party
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Troels Dreier Christensen
Principal Investigator
Locations
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Herlev & Gentofte Hospital
Herlev, Copenhagen, Denmark
Countries
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Facility Contacts
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Other Identifiers
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GI1412
Identifier Type: -
Identifier Source: org_study_id
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