Feasibility Study of Multi-Platform Profiling of Resected Biliary Tract Cancer
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ClinicalTrials.gov Identifier: NCT04561453 |
Recruitment Status :
Recruiting
First Posted : September 23, 2020
Last Update Posted : February 20, 2024
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Tracking Information | |||||
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First Submitted Date | September 11, 2020 | ||||
First Posted Date | September 23, 2020 | ||||
Last Update Posted Date | February 20, 2024 | ||||
Actual Study Start Date | July 8, 2020 | ||||
Estimated Primary Completion Date | July 31, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Feasibility Study of Multi-Platform Profiling of Resected Biliary Tract Cancer | ||||
Official Title | A Prospective Feasibility Study of Multi-Platform Profiling Using Biospecimens From Patients With Resected Biliary Tract Cancer | ||||
Brief 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. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
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. | ||||
Condition |
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Intervention | 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.
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Study Groups/Cohorts | Resected Biliary Duct Cancer
Intervention: Diagnostic Test: Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
20 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | July 1, 2025 | ||||
Estimated Primary Completion Date | July 31, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled in the study:
Exclusion Criteria: Subjects who meet any of the following criteria will not be enrolled in the study:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04561453 | ||||
Other Study ID Numbers | RG1121019 STUDY00010051 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | University of Washington | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | University of Washington | ||||
Original Study Sponsor | Same as current | ||||
Collaborators |
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Investigators |
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PRS Account | University of Washington | ||||
Verification Date | February 2024 |