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Old tumor samples may hold key to future biliary cancer treatments

NCT ID NCT07515950

Knowledge-focused Sponsor: MedSIR 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will examine stored tumor samples from 244 people diagnosed with biliary tract cancer in the last 15 years. Researchers will measure five specific markers (CLDN18.2, HER2, TROP2, PD-L1, and B7-H4) to see how common they are and how they relate to patient outcomes. The goal is to better identify which patients might benefit from targeted therapies in the future. No new treatments are given in this study.

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 244 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

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

Male and female participants with histologically confirmed biliary tract cancer (either GBC or CCA), regardless of disease stage, are eligible. Participants must have been diagnosed within the past 15 years and must have archival tumor tissue available in the form of formalin-fixed-paraffin-embedded (FFPE) samples, collected prior to the start of the Study at any disease stage (e.g., during surgery of the primary or in the advanced setting). Availability of basic clinical and survival data is required for Study participation. Confirmation of consent exemption must be obtained from the ethics committee at the time of submission.

Ages

18 years and older

Sex

Anyone

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: 1. Written informed consent for the use of clinical data and tissue samples is available. (The use of data and samples without consent is only possible if exemption is granted by the corresponding Institutional Review Board - IRB). 2. Histologically confirmed diagnosis of biliary tract cancer (including gallbladder carcinoma \[GBC\] or cholangiocarcinoma \[CCA\]), regardless of disease stage. 3. Diagnosis must have been established within the last 15 years prior to Study initiation. 4. Availability of archival formalin-fixed paraffin-embedded (FFPE) tumor tissue sample, collected prior to Study inclusion at any disease stage (e.g., during surgery or in the advanced setting). For patients with de novo metastatic disease or early stage primary tumors undergoing surgery, the tissue must have been obtained before the initiation of any systemic therapy (e.g. chemotherapy) or radiotherapy. For patients with recurrent disease undergoing a new biopsy, previous treatments are allowed. 5. Availability and accessibility of basic clinical information and survival data on medical records. Exclusion Criteria: 1. Unavailability or inadequate quality (e.g., insufficient tumor content, degraded tissue) of archival FFPE tumor tissue samples for the planned immunohistochemical analysis. 2. Missing or incomplete basic clinical and/or survival data in the medical record.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms cholangiocarcinoma gallbladder carcinoma

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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  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

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.