Status:
WITHDRAWN
Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer
Lead Sponsor:
Inova Health Care Services
Collaborating Sponsors:
Natera, Inc.
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to collect information about treatment recommendations based on ctDNA testing and whether treatment changes based on ctDNA information result in better outcomes for patien...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Resectable or borderline resectable pancreatic adenocarcinoma per NCNN guidelines
- No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer.
- ECOG performance status ≤ 1
- Clinically eligible for chemotherapy
- Able to tolerate collection of up to 20 mL of blood via venipuncture for research blood draw
- Has residual FFPE specimen available for submission to Natera
- Able to read, understand and provide written informed consent
- Willing and able to comply with the study requirements
Exclusion
- Pregnant or breastfeeding
- Radiologic evidence of distant metastases
- Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
- Prior initiation of chemotherapy, radiation therapy, or surgery for pancreatic cancer
- Neuropathy \> grade 2
- History of bone marrow or organ transplant
- Blood transfusion within 1 month of enrollment
- Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
- Serious medical condition that may adversely affect ability to participate in the study
Key Trial Info
Start Date :
August 23 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 23 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05379907
Start Date
August 23 2022
End Date
August 23 2023
Last Update
September 6 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031