Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05184400
Study type Observational
Source Herlev and Gentofte Hospital
Contact
Status Recruiting
Phase
Start date January 1, 2015
Completion date December 31, 2030

See also
  Status Clinical Trial Phase
Recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05179486 - Molecular Epidemiology of Biliary Tree Cancers
Recruiting NCT05124743 - HLA Typing and Tumor Neoantigen Identification for a Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting NCT04304781 - Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer Phase 1
Completed NCT03150615 - Enteral Nutrition After Pancreaticoduodenectomy N/A
Completed NCT01912053 - Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma Phase 2
Recruiting NCT01439698 - Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry N/A
Terminated NCT01434459 - Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin Phase 1
Completed NCT01206049 - Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations Phase 2
Recruiting NCT00973713 - Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol Phase 2
Terminated NCT00975039 - Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma Phase 2
Completed NCT00779454 - Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma Phase 2
Active, not recruiting NCT04066491 - Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L Biliary Tract Cancer (BTC) Phase 2/Phase 3
Recruiting NCT04526106 - First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors Phase 1
Recruiting NCT03603834 - Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma Phase 2
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) Phase 2
Suspended NCT04077372 - Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers N/A
Recruiting NCT04430738 - Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers Phase 1/Phase 2
Recruiting NCT05001282 - A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±) Phase 1/Phase 2
Recruiting NCT04572711 - Prospective Evaluation of Biliary Tissue Sampling With ERCP