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Bile may hold the key to guiding targeted treatment for bile duct and gallbladder cancers

NCT ID NCT07830628

NEW Diagnosis Sponsor: CHA University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers want to know whether leftover bile fluid can reveal genetic changes in tumors of people with advanced biliary tract cancer, such as bile duct or gallbladder cancer. Collecting tumor tissue for genetic testing can be difficult or risky in this cancer, so the study collects about 20 mL of bile during a drainage procedure patients already need, plus a blood sample during routine care. The team compares genetic variants found in bile and blood with those from the patient's tumor tissue to see how closely they match. About 100 patients at four hospitals in South Korea take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bile sampling for circulating tumor DNA analysis
What this could lead to
If bile testing matches tumor tissue results, it could offer a less invasive way to guide targeted treatment for biliary tract cancer.
What could go wrong
This observational study does not test a treatment, and bile may not contain enough tumor DNA to reliably match tissue results. The findings may not apply to all patients or hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of adult patients with advanced (unresectable or metastatic) biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, who are treated at 4 tertiary hospitals in South Korea. Eligible patients are those who are about to undergo clinically indicated biliary drainage (ERCP or PTBD) prior to first-line systemic anti-cancer therapy, from whom residual bile can be collected without any additional invasive procedure. Patients may be enrolled at the time of bile collection even before histologic confirmation of biliary tract cancer; however, only patients with subsequently confirmed histologic diagnosis are included in the final analysis. Enrollment is conducted on a competitive basis across participating sites, with a target of approximately 50% of enrolled patients having intrahepatic cholangiocarcinoma, given the higher frequency of actionable mutations in this subtype.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult male or female patients aged 19 years or older * Histologically confirmed advanced biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer), or clinically suspected biliary tract cancer pending histologic confirmation * Prior to first-line systemic anti-cancer therapy (patients who relapsed ≥6 months after curative surgery or adjuvant chemotherapy are eligible) * Tumor tissue next-generation sequencing (NGS) already performed or planned * Willing to provide blood and bile samples for ctDNA analysis Exclusion Criteria: * Patients from whom a bile sample cannot be obtained during clinically indicated biliary drainage (ERCP or PTBD) * Patients who decline blood sampling for ctDNA testing * Patients unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms extrahepatic bile duct carcinoma gallbladder cancer intrahepatic cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancer (BTC)

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496, South Korea

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