ctDNA Assay in Patients With Resectable Pancreatic Cancer

Pancreas Cancer Clinical Trial

— OU-SCC-ctDNA  

Official title:

Application of ctDNA Assay in the Neoadjuvant and Adjuvant Chemotherapy Setting in Patients With Resectable Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05052671
• Other study ID #: OU-SCC-ctDNA
• Status: Recruiting
• Start date: May 25, 2022
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: University of Oklahoma
• Contact: Lead Nurse
• Phone: 1-405-271-8777
• Email: SCC-IIT-office[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the proportion of positive ctDNA -freely circulating tumor DNA fragments found in the blood plasma- in patients with pancreatic cancer and to better understand the relationship between possible ctDNA biomarkers and patient survival. A successful study may provide preliminary evidence that helps improve future patient care through targeted diagnostics, prognosis, and/or treatment.

Description:

The objective of this study is to assess the role of serial ctDNA analysis as integrative biomarker in patients with resectable or borderline resectable pancreatic cancer undergoing treatment with curative intent. This is a single arm prospective tissue/blood collection from patients undergoing neoadjuvant treatment and Surgery as well as surveillance, plan to accrue up to 50 patients. Primary objective is to determine the proportion of ctDNA positive in patients with resectable pancreatic cancer and to evaluate the progression free survival (PFS) in subjects with ctDNA positive versus ctDNA negative.

Patients who consent to the study will participate in pre-study exams and tests to find out if they can take part in the study. This includes, but is not limited to, a doctor's visit with medical history and physical evaluation, blood work, pregnancy test for those capable of becoming pregnant, and imaging tests.

The study itself will include the patient's regular treatment for pancreatic cancer which may include 4 to 6 months of chemotherapy, chemo-radiation, surgery to remove pancreatic cancer, adjuvant chemotherapy and follow up for 2 years. Blood will be drawn at regular time points during this study for ctDNA detection. The tumor tissue at diagnosis will be collected to develop a personalized and tumor informed PCR test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria

1. Newly diagnosed exocrine pancreatic cancer with either pathology or radiology imaging suggestive of adenocarcinoma

2. Resectable/Borderline Resectable Pancreatic cancer as defined by the NCCN guidelines

3. = 18 years old at the time of informed consent

4. ECOG Performance Status 0 or 1

5. Patients who are candidates for neoadjuvant chemo/chemoradiotherapy or upfront surgery are eligible for the study.

6. Ability to provide written informed consent and HIPAA authorization

7. Patients must have a life expectancy of at least 6 months

Exclusion Criteria

1. Patients with pancreatic malignant tumor histologically confirmed as neuroendocrine or any other type of malignancies

2. Positive pregnancy test, pregnant, or breastfeeding

3. Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study

4. Locally advanced or metastatic disease

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
United States	University of Oklahoma	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Natera, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ctDNA Positivity in Patients with Resectable Pancreatic Cancer	Determine the proportion of ct DNA positivity in patients with resectable pancreatic cancer.	Baseline
Primary	Progression free survival (PFS)	Determine PFS in ctDNA positive versus ctDNA negative patients.	2 years
Secondary	Conversion time from ctDNA negative to positive after surgical resection.	Median time from positive ctDNA to negative ctDNA in patients with pancreatic cancer undergoing surgical resection and adjuvant chemotherapy	2 years
Secondary	Median time for select genes to convert from positive to negative.	Median time from any positive KRAS, CDKN2A, SMAD4, or TP53 genes to become negative	2 years
Secondary	Overall survival (OS) in ctDNA positive versus ctDNA negative.	Comparison of overall survival rate of ctDNA positive versus ctDNA negative patients.	2 years