Clinical trial NCT05052671: ctDNA Assay in Patients With Resectable Pancreatic Cancer
Official title: Application of ctDNA Assay in the Neoadjuvant and Adjuvant Chemotherapy Setting in Patients With Resectable Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Cancer
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Natera, Inc.
First posted: 2021-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients age 18 or over with newly diagnosed exocrine pancreatic cancer with pathology confirmed adenocarcinoma.

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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: ctDNA Positivity in Patients with Resectable Pancreatic Cancer
timeFrame: Baseline
measure: Progression free survival (PFS)
timeFrame: 2 years
Secondary outcomes:
measure: Conversion time from ctDNA negative to positive after surgical resection.
timeFrame: 2 years
measure: Median time for select genes to convert from positive to negative.
timeFrame: 2 years
measure: Overall survival (OS) in ctDNA positive versus ctDNA negative.
timeFrame: 2 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Stephenson Cancer Center- Tulsa
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Sagila George
role: PRINCIPAL_INVESTIGATOR
References: