Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Washington
With
Natera, Inc.
SEngine Precision Medicine, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects must meet all of the following criteria to be enrolled in the study:
Be ≥18 years of age.
Have a preoperative biopsy with a histopathological diagnosis consistent with a biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma or gallbladder carcinoma) or, absent a biopsy, have a clinical presentation consistent with a biliary tract cancer, and are eligible for curative resection
Surgical candidate for the requisite resection as assessed by a liver surgeon or as assessed by, if deemed necessary, a pre-operative evaluation by internal medicine, cardiology and/or anesthesia.
Pre-operative imaging showing a measurable amount of disease that, per the judgement of the surgical oncologist, will be enough to allocate to at least genomic profiling as well as the organoid creation portion of this research study.
Be willing to undergo surgical resection and willing to have the surgery performed at University of Washington.
Be willing to follow-up with medical oncology post-operatively and allow the study team to collect longitudinal data on their course as well as longitudinal blood samples for circulating tumor DNA surveillance
Have an ECOG performance status of 0-2.
Have an expected survival of ≥6 months.
Have adequate bone marrow function as evidenced by:
1. Absolute neutrophil count ≥1,000/mm3 or 1.0 ×10\^9/L
2. Hemoglobin ≥8 g/dL
3. Platelets ≥60,000/mm3 or 60 × 10\^9/L
Have adequate hepatic function as evidenced by the below, or are expected to have adequate hepatic function (as defined below) post-operatively:
1. Serum total bilirubin ≤2 × upper limit of normal (ULN), unless considered due to Gilbert's disease or a biliary obstruction
Have adequate renal function as evidenced by the below or are expected to have adequate renal function (as defined below) post-operatively:
a. Serum creatinine \<1.5 × ULN OR b. Creatinine clearance ≥50 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR) estimation: (140 - Age) x (weight in kg) x (0.85 if female)/72 x sCr
Be able to understand and willing to sign the informed consent form and to comply with scheduled visits, treatment plans, procedures, and laboratory tests, including serial peripheral blood sampling, during the study.
You may not be if
Subjects who meet any of the following criteria will not be enrolled in the study:
Mixed hepatocellular carcinoma-cholangiocarcinoma on histology.
Refuses to sign the consent.
Received any prior systemic targeted therapy (excludes chemotherapy) or an investigational agent directed at their presumed cholangiocarcinoma prior to resection
Received any prior radiation or catheter-directed therapy to the malignant tumor being resected, unless there has been definitive malignant progression of that tumor since the time of the post-treatment imaging assessment after radiation or catheter-directed therapy.
Received any systemic anticancer therapy or an investigational agent for another indication (a synchronous cancer of a different primary site) in the 6 months prior to discovery of their presumed cholangiocarcinoma by imaging
Have known extrahepatic metastases or locally advanced disease precluding resection of the cholangiocarcinoma.
Have a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid or liquid tumor with no known active disease present that, in the opinion of the Investigator, will not affect subject outcome in the setting of current cholangiocarcinoma diagnosis.
Are pregnant or breastfeeding
Have any other acute or chronic medical or psychiatric condition, including recent (within 12 months of cholangiocarcinoma diagnosis) or active suicidal ideation or behavior, or a laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
Have been committed to an institution by virtue of an order issued either by the judicial or administrative authorities.
Are dependent on the Sponsor, Investigator, or study site, per local institution regulations.
