NCT04561453

Feasibility Study of Multi-Platform Profiling of Resected Biliary Tract Cancer

A Prospective Feasibility Study of Multi-Platform Profiling Using Biospecimens From Patients With Resected Biliary Tract Cancer

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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
• Hilar Cholangiocarcinoma
• Distal Bile Duct Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring	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.

Timeline

• Start date: 2020-07-08
• Primary completion: 2024-12-31
• Completion: 2025-04-04
• First posted: 2020-09-23
• Last updated: 2025-07-10

Locations

2 sites across 1 country: United States