Recruiting

ctDNA Assay

Sponsor:

University of Oklahoma

Code:

NCT05052671

Conditions

Pancreas Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05052671

Start date

May 25, 2022

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • ctDNA Positivity in Patients with Resectable Pancreatic Cancer [ Time Frame: Baseline ]
  • Progression free survival (PFS) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Lead Nurse

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

Locations

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73117

Contacts

Lead Nurse

405-271-8777SCC-IIT-Office@ouhsc.edu

Principal Investigator:

Sagila George, MD

More Information

Sponsor

University of Oklahoma

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-03-05.