Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Cholangiocarcinoma

Klatskin Tumor

Biliary Tract Neoplasms

Gallbladder Neoplasms

Bile Duct Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Bile Duct Diseases

Bile Duct Cancer

Biliary Tract Cancer

Gallbladder Cancer

Intrahepatic Cholangiocarcinoma

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.

Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring

Gentry King, MD

Shikha Jain, MD

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.

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

The investigators will measure the percentage of patients for whom organoids are able to be successfully cultured and subjected to a drug screen.

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.

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.

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.

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.

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.

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.

The investigators will correlate ctDNA level trends with radiographic responses to medical treatments.

Natera, Inc.

SEngine Precision Medicine, Inc.

University of Washington

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Treatment will be recommended after reviewing the profiling analysis

treated recommended

Stephen Anthony, DO

This study will use proteomic and genomic profiling to analyze tumor tissue to see if treatment selected by this analysis will benefit patients.

To examine the impact of targeted therapy for breast cancer based upon proteomic and genomic profiling using RPMA, IHC analysis, RNA-Seq, and Exome sequencing on PFS and GMI.

A Pilot Study Utilizing Proteomic and Genomic Profiling for Patients With Metastatic Breast Cancer

A Pilot Study Utilizing Proteomic and Genomic Profiling by Reverse Phase Protein Microarray (RPMA), IHC Analysis, RNA Seq, and Exome Sequencing of Patients' Tumors to Find Potential Targets and Select Treatments for Patients With Metastatic Breast Cancer

The data from this exploratory analysis will help generate the hypothesis for a future prospective study.

Determine the impact of targeted therapy for breast cancer based upon proteomic and genomic profiling using RPMA, IHC analysis, RNA-Seq, and Exome sequencing on PFS and GMI.

Record the frequency with which proteomic, IHC, and genomic profiling analysis of a patient's tumor by RPMA, IHC analysis, RNA-Seq, and Exome sequencing yields a target against which there is an FDA-approved agent or therapeutic regimen.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility Study of Multi-Platform Profiling of Resected Biliary Tract Cancer	NCT04561453	Biliary Tract C... Cholangiocarcin... Gallbladder Can... Intrahepatic Ch... Perihilar Chola... Extrahepatic Ch... Hilar Cholangio... Distal Bile Duc...	Multi-Platform ...	18 Years -	University of Washington
A Pilot Study Utilizing Proteomic and Genomic Profiling for Patients With Metastatic Breast Cancer	NCT01919749	Metastatic Brea...	treated recomme...	18 Years -	Translational Drug Development
A Pilot Study Utilizing Proteomic and Genomic Profiling for Patients With Metastatic Breast Cancer	NCT01919749	Metastatic Brea...	treated recomme...	18 Years -	Translational Drug Development

Spots Global Cancer Trial Database for profiling

Every month we try and update this database with for profiling cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for profiling

Every month we try and update this database with for profiling cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for profiling cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.