Biliary Tract CancerNCT04561453
Feasibility Study of Multi-Platform Profiling of Resected Biliary Tract Cancer
An observational study of Biliary Tract Cancer and Cholangiocarcinoma, run by University of Washington at 2 sites in United States.
Trial summary
This study is going to test the ability to successfully obtain results from certain personalized tests for patients with biliary tract cancers that are able to be surgically removed. 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
- What is being tested?
- Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jul 2020to 4 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Study participants will be selected from a group of individuals being evaluated at University of Washington and the Seattle Cancer Care Alliance for a liver mass that is suspected to be localized biliary tract cancer amenable to resection.
Who may be able to join
- Subjects must meet all of the following criteria to be enrolled in the study:
- Be ≥18 years of age.
- Have a preoperative biopsy with a histopathological diagnosis consistent with a biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma or gallbladder carcinoma) or, absent a biopsy, have a clinical presentation consistent with a biliary tract cancer, and are eligible for curative resection
- Surgical candidate for the requisite resection as assessed by a liver surgeon or as assessed by, if deemed necessary, a pre-operative evaluation by internal medicine, cardiology and/or anesthesia.
- Pre-operative imaging showing a measurable amount of disease that, per the judgement of the surgical oncologist, will be enough to allocate to at least genomic profiling as well as the organoid creation portion of this research study.
- Be willing to undergo surgical resection and willing to have the surgery performed at University of Washington.
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- Be willing to follow-up with medical oncology post-operatively and allow the study team to collect longitudinal data on their course as well as longitudinal blood samples for circulating tumor DNA surveillance
- Have an ECOG performance status of 0-2.
- Have an expected survival of ≥6 months.
- Have adequate bone marrow function as evidenced by:
- Absolute neutrophil count ≥1,000/mm3 or 1.0 ×10^9/L
- Hemoglobin ≥8 g/dL
- Platelets ≥60,000/mm3 or 60 × 10^9/L
- Have adequate hepatic function as evidenced by the below, or are expected to have adequate hepatic function (as defined below) post-operatively:
- Serum total bilirubin ≤2 × upper limit of normal (ULN), unless considered due to Gilbert's disease or a biliary obstruction
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤8 × ULN
- Have adequate renal function as evidenced by the below or are expected to have adequate renal function (as defined below) post-operatively:
- Serum creatinine <1.5 × ULN OR b. Creatinine clearance ≥50 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR) estimation: (140 - Age) x (weight in kg) x (0.85 if female)/72 x sCr
- Be able to understand and willing to sign the informed consent form and to comply with scheduled visits, treatment plans, procedures, and laboratory tests, including serial peripheral blood sampling, during the study.
Who cannot join
- Subjects who meet any of the following criteria will not be enrolled in the study:
- Mixed hepatocellular carcinoma-cholangiocarcinoma on histology.
- Refuses to sign the consent.
- Received any prior systemic targeted therapy (excludes chemotherapy) or an investigational agent directed at their presumed cholangiocarcinoma prior to resection
- Received any prior radiation or catheter-directed therapy to the malignant tumor being resected, unless there has been definitive malignant progression of that tumor since the time of the post-treatment imaging assessment after radiation or catheter-directed therapy.
- Received any systemic anticancer therapy or an investigational agent for another indication (a synchronous cancer of a different primary site) in the 6 months prior to discovery of their presumed cholangiocarcinoma by imaging
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- Have known extrahepatic metastases or locally advanced disease precluding resection of the cholangiocarcinoma.
- Have a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid or liquid tumor with no known active disease present that, in the opinion of the Investigator, will not affect subject outcome in the setting of current cholangiocarcinoma diagnosis.
- Are pregnant or breastfeeding
- Have any other acute or chronic medical or psychiatric condition, including recent (within 12 months of cholangiocarcinoma diagnosis) or active suicidal ideation or behavior, or a laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- Have been committed to an institution by virtue of an order issued either by the judicial or administrative authorities.
- Are dependent on the Sponsor, Investigator, or study site, per local institution regulations.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Washington
Seattle, Washington, 98195
About this study
Official title: A Prospective Feasibility Study of Multi-Platform Profiling Using Biospecimens From Patients With Resected Biliary Tract Cancer
This study is going to test the ability to successfully obtain results from certain personalized tests for patients with biliary tract cancers that are able to be surgically removed. Through surveys, this study will also evaluate the usefulness of these tests to medical oncologists as they make decisions on what standard or experimental treatments might benefit the patient's enrolled in the study. The study is observational and does not require any change in the standard approach to treating biliary tract cancer. Results of the personalized tests will be provided to the treating medical oncologist and the medical oncologist can choose to whether or not to change management based on these results. These personalized tests include reading of the cancer DNA, testing whether a panel of drugs can kill a patient's cancer cells in a test tube, and testing for small amounts of cancer DNA in the blood as a way to check for the presence of leftover cancer in the body after it is removed surgically. This study will also give extra pieces of cancer, that would otherwise be discarded, from surgery for laboratory research into how biliary tract cancers respond to drugs and the body's immune system. The investigators hypothesize that the drug screen test will, in some cases, be useful to the medical oncologist and may lead to the use of cancer drugs that would not otherwise have been chosen based on standard guidelines or based on cancer DNA testing. The investigators hypothesize that the test tube drug screening method will correlate with how the cancer responds to the drugs in real life for those patients that end up receiving a drug that was included in the drug screen panel. The investigators hypothesize that monitoring of cancer DNA in the blood stream will help us predict which patients are most likely to have their cancer return after surgery. The investigators also hypothesize that in many cases the appearance of cancer DNA in the blood stream will happen weeks to months prior to the cancer showing up on usual body imaging or other lab tests. Finally, the investigators hypothesize that, for patients undergoing medical treatment for their cancer, trends in the amount of cancer DNA in the blood stream will correlate with the effectiveness of treatment.
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer, Intrahepatic Cholangiocarcinoma, Perihilar Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma
- Being tested
- Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring
- Keywords
- organoid, circulating tumor DNA, ctDNA, drug screen, profiling, feasibility
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms, Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA MonitoringDiagnostic test
All patients in the study will have organoid creation and organoid drug sensitivity screening attempted on their fresh tumor tissue from surgical resection. All patients will also have blood taken pre-operatively and at multiple post-operative time points to monitor circulating tumor DNA.
| Study group | Role | What they receive |
|---|---|---|
| Resected Biliary Duct Cancer | Not described Receives: Diagnostic Test: Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Organoid Culture and Drug Screen
The investigators will measure the percentage of patients for whom organoids are able to be successfully cultured and subjected to a drug screen.
Measured: Within 12 weeks after surgery
Success Rate of Obtaining circulating tumor DNA (ctDNA) quantification and Ability to assess change in ctDNA levels across those time points
The investigators will measure the percentage of patients for whom ctDNA was able to be collected and quantified at multiple key time points across the course of a patient's treatment.
Measured: Through study completion, an average of 4 years.
Secondary outcomes (6)
Physician-Adjudicated Utility of Profiling Test Results - Post-Adjuvant Therapy
Through surveys, the investigators will ask cancer physicians how helpful the profiling test results are anticipated to be to the ultimate management of the patient after they have received adjuvant chemotherapy.
Measured: At the time of completion of adjuvant therapy, on average 6 months after surgery.
Prospective Concordance of Organoid Drug Screen Results and In Vivo Drug Activity
For patients that are treated with drugs that were also evaluated by the initial organoid drug screen, the investigators will measure how often the organoid's response to the drug paralleled the response of the cancer to the drug when administered to the patient.
Measured: Through study completion, an average of 4 years.
Predictive Value of circulating tumor DNA (ctDNA) for Recurrence
The investigators will evaluate how often measurable post-operative ctDNA levels were able to predict ultimate recurrence of clinical disease. The investigators will measure the lead time of ctDNA-assessed recurrence over radiographic recurrence.
Measured: From date of randomization until the date of first documented radiographic recurrence, an average of 2 years after surgery.
Concordance of Organoid Drug Screen Results with Next Generation Sequencing (NGS)-Predicted Drug Sensitivities
The investigators will evaluate how often the organoid drug screen responded to a drug that genomic profiling by NGS would have predicted the cancer would be sensitive to.
Measured: Within 12 weeks after surgery when results of NGS and Organoid Drug Screen have returned.
Physician-Adjudicated Utility of Profiling Test Results - At Time of Recurrence
Through surveys, the investigators will ask cancer physicians how helpful the profiling test results were to the ultimate management of the patient at the time their cancer recurred.
Measured: At the time of cancer recurrence, on average 24 months after surgery.
Predictive Value of circulating tumor DNA (ctDNA) for Response to Medical Therapy
The investigators will correlate ctDNA level trends with radiographic responses to medical treatments.
Measured: Through study completion, an average of 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start8 Jul 2020
- Primary completion31 Dec 2024
- Study completion4 Apr 2025
Why it stopped: Study terminated due to end of funding
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.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Natera, Inc., SEngine Precision Medicine, Inc.
- Responsible party
- Sponsor
- Investigators
- Gentry King, MD, Principal investigator, University of Washington Seattle Cancer Care Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561453
- Sponsor's protocol ID
- RG1121019
- Other IDs
- STUDY00010051
- Status last verified
- Jul 2025
- First submitted
- 11 Sep 2020
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Study of Multi-Platform Profiling Using Biospecimens From Patients With Resected Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT04561453
- Acronym / sponsor ID
- RG1121019
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer, Intrahepatic Cholangiocarcinoma, Perihilar Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma
- Keywords
- organoid, circulating tumor DNA, ctDNA, drug screen, profiling, feasibility
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated due to end of funding
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Natera, Inc., SEngine Precision Medicine, Inc.
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 23 Sep 2020 (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.
This study is going to test the ability to successfully obtain results from certain personalized tests for patients with biliary tract cancers that are able to be surgically removed. Through surveys, this study will also evaluate the usefulness of these tests to medical oncologists as they make decisions on what standard or experimental treatments might benefit the patient's enrolled in the study. The study is observational and does not require any change in the standard approach to treating biliary tract cancer. Results of the personalized tests will be provided to the treating medical oncologist and the medical oncologist can choose to whether or not to change management based on these results. These personalized tests include reading of the cancer DNA, testing whether a panel of drugs can kill a patient's cancer cells in a test tube, and testing for small amounts of cancer DNA in the blood as a way to check for the presence of leftover cancer in the body after it is removed surgically. This study will also give extra pieces of cancer, that would otherwise be discarded, from surgery for laboratory research into how biliary tract cancers respond to drugs and the body's immune system. The investigators hypothesize that the drug screen test will, in some cases, be useful to the medical oncologist and may lead to the use of cancer drugs that would not otherwise have been chosen based on standard guidelines or based on cancer DNA testing. The investigators hypothesize that the test tube drug screening method will correlate with how the cancer responds to the drugs in real life for those patients that end up receiving a drug that was included in the drug screen panel. The investigators hypothesize that monitoring of cancer DNA in the blood stream will help us predict which patients are most likely to have their cancer return after surgery. The investigators also hypothesize that in many cases the appearance of cancer DNA in the blood stream will happen weeks to months prior to the cancer showing up on usual body imaging or other lab tests. Finally, the investigators hypothesize that, for patients undergoing medical treatment for their cancer, trends in the amount of cancer DNA in the blood stream will correlate with the effectiveness of treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resected Biliary Duct Cancer | – | Diagnostic Test: Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from a group of individuals being evaluated at University of Washington and the Seattle Cancer Care Alliance for a liver mass that is suspected to be localized biliary tract cancer amenable to resection.
Key inclusion criteria (19 listed)
- Be ≥18 years of age.
- Have a preoperative biopsy with a histopathological diagnosis consistent with a biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma or gallbladder carcinoma) or, absent a biopsy, have a clinical presentation consistent with a biliary tract cancer, and are eligible for curative resection
- Surgical candidate for the requisite resection as assessed by a liver surgeon or as assessed by, if deemed necessary, a pre-operative evaluation by internal medicine, cardiology and/or anesthesia.
- Pre-operative imaging showing a measurable amount of disease that, per the judgement of the surgical oncologist, will be enough to allocate to at least genomic profiling as well as the organoid creation portion of this research study.
- Be willing to undergo surgical resection and willing to have the surgery performed at University of Washington.
Key exclusion criteria (12 listed)
- Mixed hepatocellular carcinoma-cholangiocarcinoma on histology.
- Refuses to sign the consent.
- Received any prior systemic targeted therapy (excludes chemotherapy) or an investigational agent directed at their presumed cholangiocarcinoma prior to resection
- Received any prior radiation or catheter-directed therapy to the malignant tumor being resected, unless there has been definitive malignant progression of that tumor since the time of the post-treatment imaging assessment after radiation or catheter-directed therapy.
- Received any systemic anticancer therapy or an investigational agent for another indication (a synchronous cancer of a different primary site) in the 6 months prior to discovery of their presumed cholangiocarcinoma by imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA MonitoringAll patients in the study will have organoid creation and organoid drug sensitivity screening attempted on their fresh tumor tissue from surgical resection. All patients will also have blood taken pre-operatively and at multiple post-operative time points to monitor circulating tumor DNA. | Diagnostic test | Resected Biliary Duct Cancer |
Primary outcome
Success Rate of Organoid Culture and Drug Screen
Time frame: Within 12 weeks after surgery
The investigators will measure the percentage of patients for whom organoids are able to be successfully cultured and subjected to a drug screen.
Success Rate of Obtaining circulating tumor DNA (ctDNA) quantification and Ability to assess change in ctDNA levels across those time points
Time frame: Through study completion, an average of 4 years.
The investigators will measure the percentage of patients for whom ctDNA was able to be collected and quantified at multiple key time points across the course of a patient's treatment.
6 secondary outcomes
Physician-Adjudicated Utility of Profiling Test Results - Post-Adjuvant Therapy
Time frame: At the time of completion of adjuvant therapy, on average 6 months after surgery.
Prospective Concordance of Organoid Drug Screen Results and In Vivo Drug Activity
Time frame: Through study completion, an average of 4 years.
Predictive Value of circulating tumor DNA (ctDNA) for Recurrence
Time frame: From date of randomization until the date of first documented radiographic recurrence, an average of 2 years after surgery.
Concordance of Organoid Drug Screen Results with Next Generation Sequencing (NGS)-Predicted Drug Sensitivities
Time frame: Within 12 weeks after surgery when results of NGS and Organoid Drug Screen have returned.
Physician-Adjudicated Utility of Profiling Test Results - At Time of Recurrence
Time frame: At the time of cancer recurrence, on average 24 months after surgery.
Predictive Value of circulating tumor DNA (ctDNA) for Response to Medical Therapy
Time frame: Through study completion, an average of 4 years.
Results and safety
The study was stopped early (reason given: Study terminated due to end of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
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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. This study is not recruiting at the moment.
Gentry King, MD principal investigator
University of Washington Seattle Cancer Care Alliance
2 sites 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 University of Washington at 2 sites in United States.
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 19 inclusion and 12 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: stopped early, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study was stopped early (reason given: Study terminated due to end of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate of Organoid Culture and Drug Screen (time frame: Within 12 weeks after surgery). 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 10 Jul 2025.