Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05184400 |
| Other study ID # |
GI1412 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2015 |
| Est. completion date |
December 31, 2030 |
Study information
| Verified date |
December 2021 |
| Source |
Herlev and Gentofte Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
Biliary tract cancer (BTC) is a heterogeneous disease and includes both gallbladder cancer
and cholangiocarcinoma. Combined BTC is the fifth most common gastrointestinal cancer. The
prognosis is poor with a median overall survival of less than a year and estimated 5-year
survival of about 20 % for all stages. The poor survival is related to aggressive malign
nature, late diagnosis, and limited treatment options. Today, only CA 19-9 is used in routine
practice but its use as a prognostic or diagnostic biomarker is very limited.
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.
