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 : January 20, 2022
|Condition or disease||Intervention/treatment|
|Biliary Tract Cancer Cholangiocarcinoma Gallbladder Cancer Intrahepatic Cholangiocarcinoma Perihilar Cholangiocarcinoma Extrahepatic Cholangiocarcinoma Hilar Cholangiocarcinoma Distal Bile Duct Cancer||Diagnostic Test: Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||A Prospective Feasibility Study of Multi-Platform Profiling Using Biospecimens From Patients With Resected Biliary Tract Cancer|
|Actual Study Start Date :||July 8, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||July 1, 2025|
|Resected Biliary Duct Cancer||
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.
- 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.
- 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. ]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.
- Prospective Concordance of Organoid Drug Screen Results and In Vivo Drug Activity [ Time Frame: Through study completion, an average of 4 years. ]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.
- 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. ]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.
- 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. ]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.
- 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. ]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.
- Predictive Value of circulating tumor DNA (ctDNA) for Response to Medical Therapy [ Time Frame: Through study completion, an average of 4 years. ]The investigators will correlate ctDNA level trends with radiographic responses to medical treatments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04561453
|Contact: Gentry King, MD||206 606 email@example.com|
|United States, Illinois|
|University of Illinois at Chicago||Not yet recruiting|
|Chicago, Illinois, United States, 60612|
|Principal Investigator: Shikha Jain, MD|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Gentry King, MD 206-606-2494 firstname.lastname@example.org|
|Principal Investigator: Gentry King, MD|
|Principal Investigator:||Gentry King, MD||University of Washington Seattle Cancer Care Alliance|