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PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples | Clinical Trials | Clareo Health

RECRUITINGPHASE2

PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples

NCT04683315•Medical College of Wisconsin

View on ClinicalTrials.gov

Summary

This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer.

Detailed Description

The study intervention involves molecular profiling Purity Independent Subtyping of Tumors (PurIST) subtyping of pretreatment Endoscopic Ultrasound Fine Needle Aspiration (EUS/FNA) samples to determine pancreatic cancer subtype. Neoadjuvant therapy is directed based on the molecular subtype (classical vs. basal). Patients with classical subtype will receive a standard chemotherapy (mFOLFIRINOX) and patients with basal subtype will receive an alternative standard therapy (gemcitabine/nab-paclitaxel).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Have suspicion of pancreas adenocarcinoma and plan for endoscopic biopsy.
•2. Plan for endoscopic biopsy or agreeable to an additional EUS/FNA for research purposes, otherwise plan to obtain archival tissue for PurlST testing.
•1. Be 18 years of age or older.
•2. Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
•3. Have documentation of histologically confirmed adenocarcinoma.
•4. Have an Eastern Cooperative Group (ECOG) performance status \< 2.
•5. Have clinical stage consistent with resectable, borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.
•6. Have adequate organ and bone marrow function, as defined by
•* total leukocytes \>3 x103/μL.
•* absolute neutrophil count (ANC) \>1.5x 103/μL.
+26 more criteria

Exclusion Criteria

•1. Has received chemotherapy and/or radiation within three years prior to study enrollment.
•2. Has any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in situ carcinoma of the cervix or localized prostate cancer with normal prostate specific antigen) within three years of study enrollment.
•3. Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity (BMI \>55) or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
•4. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
•5. Pregnant or breastfeeding patients or any patient with childbearing potential not using contraception four weeks prior to treatment.

Locations (2)

HonorHealth Medical Group

Scottsdale, Arizona, United States

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

April 1, 2021

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2028

Last Updated

March 5, 2026

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

mFOLFIRINOX Treatment Regimen

DRUG

Gemcitabine/Nab-paclitaxel Treatment Regimen

DRUG

Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505 cccto@mcw.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples

Inclusion Criteria

Exclusion Criteria

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