Biliary Tract CancerCHOCANCT05184400
Identification of New Biomarkers for Patients With Cholangiocarcinoma and Gallbladder Cancer
An observational study of Biliary Tract Cancer and Cholangiocarcinoma, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2015to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Histological or cytological diagnosis of BTC
- Patients referred for treatment of BTC
- Signed informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Herlev & Gentofte Hospital
Herlev, Copenhagen, 2700
Troels D Christensen, MD, +4538681381, troels.dreier.christensen.01@regionh.dk
Julia S Johansen, D.M.Sc. MD, +4538689241, Julia.Sidenius.Johansen@regionh.dk
About this study
Official title: 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?
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.
Read the detailed 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.
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Keywords
- Prospective observational open cohort study, Biomarkers, Diagnostics, Prognostics, Prediction of treatment efficacy
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy (sensitivity and specificity)
Outcome for diagnostic biomarkers. Case-control design.
Measured: Baseline
Overall survival (OS)
Outcome for prognostic and predictive biomarkers
Measured: Baseline to death or lost to follow-up, an average of 1 year
Secondary outcomes (2)
Progression free survival (PFS)
Outcome for prognostic and predictive biomarkers
Measured: Baseline to progression, death or lost to follow-up, an average of 1 year
Incidence of adverse events
Outcome for prognostic and predictive biomarkers related to treatment toxicity.
Measured: Baseline to progression, death or lost to follow-up, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jan 2015
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Troels Dreier Christensen, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184400
- Sponsor's protocol ID
- GI1412
- Acronym
- CHOCA
- Status last verified
- Dec 2021
- First submitted
- 21 Oct 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT05184400
- Acronym / sponsor ID
- CHOCA / GI1412
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Keywords
- Prospective observational open cohort study, Biomarkers, Diagnostics, Prognostics, Prediction of treatment efficacy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Histological or cytological diagnosis of BTC
- Patients referred for treatment of BTC
- Signed informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy (sensitivity and specificity)
Time frame: Baseline
Outcome for diagnostic biomarkers. Case-control design.
Overall survival (OS)
Time frame: Baseline to death or lost to follow-up, an average of 1 year
Outcome for prognostic and predictive biomarkers
2 secondary outcomes
Progression free survival (PFS)
Time frame: Baseline to progression, death or lost to follow-up, an average of 1 year
Incidence of adverse events
Time frame: Baseline to progression, death or lost to follow-up, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Cancer and Cholangiocarcinoma, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (sensitivity and specificity) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.