RECRUITING

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

Conditions

Pancreatic Cancer molecular profiling neoadjuvant pancreatic adenocarcinoma pancreas cancer CA19-9 surgery MCW

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-04-01

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04683315

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

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.

Contacts and Locations

Study Contact

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505

cccto@mcw.edu

Principal Investigator

Kathleen K Christians, MD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

HonorHealth Medical Group

Scottsdale, Arizona, 85258-4566

United States

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Kathleen K Christians, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-01

Study Completion Date2027-06

Study Record Updates

Study Start Date2021-04-01

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

molecular profiling
neoadjuvant
pancreatic adenocarcinoma
pancreas cancer
CA19-9
surgery
MCW

Additional Relevant MeSH Terms

Pancreatic Cancer