ctDNA Assay in Patients With Resectable Pancreatic Cancer

Recruiting

• Conditions: Pancreas Cancer

• Registration Number: NCT05052671
• Lead Sponsor: University of Oklahoma

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-22
• Study Start: 2022-05-25
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13
• Primary Completion: 2024-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ctDNA Positivity in Patients with Resectable Pancreatic Cancer	Baseline	Determine the proportion of ct DNA positivity in patients with resectable pancreatic cancer.
Progression free survival (PFS)	2 years	Determine PFS in ctDNA positive versus ctDNA negative patients.

Secondary Outcome Measures

Name	Time	Method
Median time for select genes to convert from positive to negative.	2 years	Median time from any positive KRAS, CDKN2A, SMAD4, or TP53 genes to become negative
Conversion time from ctDNA negative to positive after surgical resection.	2 years	Median time from positive ctDNA to negative ctDNA in patients with pancreatic cancer undergoing surgical resection and adjuvant chemotherapy
Overall survival (OS) in ctDNA positive versus ctDNA negative.	2 years	Comparison of overall survival rate of ctDNA positive versus ctDNA negative patients.

Trial Locations

Locations (1)

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States