Identification of New Biomarkers for Patients With Cholangiocarcinoma and Gallbladder Cancer
CHOCA
1 other identifier
observational
500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 21, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
January 11, 2022
December 1, 2021
16 years
October 21, 2021
December 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Diagnostic accuracy (sensitivity and specificity)
Outcome for diagnostic biomarkers. Case-control design.
Baseline
Overall survival (OS)
Outcome for prognostic and predictive biomarkers
Baseline to death or lost to follow-up, an average of 1 year
Secondary Outcomes (2)
Progression free survival (PFS)
Baseline to progression, death or lost to follow-up, an average of 1 year
Incidence of adverse events
Baseline to progression, death or lost to follow-up, an average of 1 year
Eligibility Criteria
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.
You may qualify if:
- Histological or cytological diagnosis of BTC
- Patients referred for treatment of BTC
- Signed informed consent
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Herlev & Gentofte Hospital
Herlev, Copenhagen, 2700, Denmark
Biospecimen
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 every time of CT scan until disease progression. Tissue removed during routine diagnostic procedures or treatment will be requisitioned.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 21, 2021
First Posted
January 11, 2022
Study Start
January 1, 2015
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
January 11, 2022
Record last verified: 2021-12