Pancreas CancerOU-SCC-ctDNANCT05052671
ctDNA Assay in Patients With Resectable Pancreatic Cancer
An observational study of Pancreas Cancer, run by University of Oklahoma at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pancreas Cancer
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 May 2022to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients age 18 or over with newly diagnosed exocrine pancreatic cancer with pathology confirmed adenocarcinoma.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Oklahoma
Oklahoma City, Oklahoma, 73117
Lead Nurse, 405-271-8777, SCC-IIT-Office@ouhsc.edu
Sagila George, MD
- Recruiting
Stephenson Cancer Center- Tulsa
Tulsa, Oklahoma, 74104
Lead Nurse, SCC-IIT-Office@ouhsc.edu
Laura K Brett, MD
About this study
Official title: Application of ctDNA Assay in the Neoadjuvant and Adjuvant Chemotherapy Setting in Patients With Resectable Pancreatic Cancer
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.
Read the 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, 24 weeks of post operative ctDNA surveillance 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.
- Conditions
- Pancreas Cancer
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA Positivity in Patients with Resectable Pancreatic Cancer
Determine the proportion of ct DNA positivity in patients with resectable pancreatic cancer.
Measured: Baseline
Progression free survival (PFS)
Determine PFS in ctDNA positive versus ctDNA negative patients.
Measured: 2 years
Secondary outcomes (3)
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
Measured: 2 years
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
Measured: 2 years
Overall survival (OS) in ctDNA positive versus ctDNA negative.
Comparison of overall survival rate of ctDNA positive versus ctDNA negative patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start25 May 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Natera, Inc.
- Responsible party
- Sponsor
- Investigators
- Sagila George, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052671
- Sponsor's protocol ID
- OU-SCC-ctDNA
- Acronym
- OU-SCC-ctDNA
- Status last verified
- Oct 2026
- First submitted
- 13 Sep 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of ctDNA Assay in the Neoadjuvant and Adjuvant Chemotherapy Setting in Patients With Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05052671
- Acronym / sponsor ID
- OU-SCC-ctDNA / OU-SCC-ctDNA
- Conditions
- Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Natera, Inc.
- Study start
- 25 May 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 24 weeks of post operative ctDNA surveillance 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients age 18 or over with newly diagnosed exocrine pancreatic cancer with pathology confirmed adenocarcinoma.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ctDNA Positivity in Patients with Resectable Pancreatic Cancer
Time frame: Baseline
Determine the proportion of ct DNA positivity in patients with resectable pancreatic cancer.
Progression free survival (PFS)
Time frame: 2 years
Determine PFS in ctDNA positive versus ctDNA negative patients.
3 secondary outcomes
Conversion time from ctDNA negative to positive after surgical resection.
Time frame: 2 years
Median time for select genes to convert from positive to negative.
Time frame: 2 years
Overall survival (OS) in ctDNA positive versus ctDNA negative.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sagila George principal investigator
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lead Nurse (1-405-271-8777, SCC-IIT-office@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA Positivity in Patients with Resectable Pancreatic Cancer (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.