Actively Recruiting
Identification of New Biomarkers for Patients With Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer) - do They Provide New Information Regarding Diagnosis, Treatment Efficacy, Side Effects, or Prognosis?
Led by Herlev and Gentofte Hospital · Updated on 2022-01-11
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Biliary tract cancer (BTC), including cholangiocarcinoma and gallbladder cancer, is a serious disease with a poor prognosis and limited treatment options. This research aims to find new biomarkers that can help diagnose BTC earlier, predict treatment outcomes, and improve understanding of the disease. Currently, only one biomarker, CA 19-9, is used but has limited value for predicting diagnosis or prognosis. This observational study collects biological samples such as blood and tissue from patients diagnosed with BTC who are receiving standard or protocolized treatment. Samples are taken before surgery or chemotherapy, during treatment, and at regular follow-up visits about every three months. Clinical data including patient demographics, disease details, treatments, blood tests, and outcomes are also collected and analyzed. Participants will be followed until death, with regular monitoring of disease progression and survival. Researchers will analyze various molecules like DNA, RNA, proteins, and metabolites to identify useful biomarkers. The main outcomes measured are diagnostic accuracy and overall survival, along with progression-free survival and adverse events, to better understand BTC and improve patient care.
CONDITIONS
Brief Title
Identification of New Biomarkers for Patients With Cholangiocarcinoma and Gallbladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological diagnosis of biliary tract cancer
- Patients referred for treatment of biliary tract cancer
- Signed informed consent
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline before operation or start of chemotherapy
Participants provide biological samples and clinical data before starting treatment to identify diagnostic and prognostic biomarkers.
1 visit (in-person)
Duration - From treatment start until disease progression, death, or loss to follow-up (average 1 year)
Participants are monitored with blood sampling during treatment and follow-up CT scans approximately every 3 months to assess treatment effectiveness and disease progression.
Blood samples before 2nd chemotherapy cycle and approximately every 3 months during follow-up
Duration - Until death
Participants are followed until death to collect clinical outcomes and biomarker data over time.
Periodic assessments as per routine follow-up
Trial Site Locations
Total: 1 location
1
Herlev & Gentofte Hospital
Herlev, Copenhagen, Denmark, 2700
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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