ctDNA Assay in Patients With Resectable Pancreatic Cancer

NCT05052671 | Recruiting

• 1 other identifier: OU-SCC-ctDNA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreas Cancer

Outcome Measures

Primary Outcomes (2)

• ctDNA Positivity in Patients with Resectable Pancreatic Cancer

  Determine the proportion of ct DNA positivity in patients with resectable pancreatic cancer.

  Baseline

• Progression free survival (PFS)

  Determine PFS in ctDNA positive versus ctDNA negative patients.

  2 years

Secondary Outcomes (3)

• Conversion time from ctDNA negative to positive after surgical resection.

  2 years

• Median time for select genes to convert from positive to negative.

  2 years

• Overall survival (OS) in ctDNA positive versus ctDNA negative.

  2 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients age 18 or over with newly diagnosed exocrine pancreatic cancer with pathology confirmed adenocarcinoma.

You may qualify if:

• Newly diagnosed exocrine pancreatic cancer with either pathology or radiology imaging suggestive of adenocarcinoma
• Resectable/Borderline Resectable Pancreatic cancer as defined by the NCCN guidelines
• ≥ 18 years old at the time of informed consent
• ECOG Performance Status 0 or 1
• Patients who are candidates for neoadjuvant chemo/chemoradiotherapy or upfront surgery are eligible for the study.
• Ability to provide written informed consent and HIPAA authorization
• Patients must have a life expectancy of at least 6 months

You may not qualify if:

• Patients with pancreatic malignant tumor histologically confirmed as neuroendocrine or any other type of malignancies
• Positive pregnancy test, pregnant, or breastfeeding
• Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study
• Locally advanced or metastatic disease

Sponsors & Collaborators

• University of Oklahoma: lead
• Natera, Inc.: collaborator

Study Sites (2)

University of Oklahoma

Oklahoma City, Oklahoma, 73117, United States

RECRUITING

Stephenson Cancer Center- Tulsa

Tulsa, Oklahoma, 74104, United States

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue from core biopsy and blood sample for ctDNA assay.

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Sagila George

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lead Nurse

CONTACT

1-405-271-8777; SCC-IIT-office@ouhsc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: May 25, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)