Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer

Inova Health Care Services

Status: Withdrawn

Conditions: Pancreatic Cancer

Treatments: Other: SIGNATERA™ ctDNA testing

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05379907

U22-02-4671

Details and patient eligibility

About

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 patients with pancreatic cancer.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years of age or older
2. Resectable or borderline resectable pancreatic adenocarcinoma per NCNN guidelines
3. No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer.
4. ECOG performance status ≤ 1
5. Clinically eligible for chemotherapy
6. Able to tolerate collection of up to 20 mL of blood via venipuncture for research blood draw
7. Has residual FFPE specimen available for submission to Natera
8. Able to read, understand and provide written informed consent
9. Willing and able to comply with the study requirements

Exclusion criteria

1. Pregnant or breastfeeding
2. Radiologic evidence of distant metastases
3. Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
4. Prior initiation of chemotherapy, radiation therapy, or surgery for pancreatic cancer
5. Neuropathy > grade 2
6. History of bone marrow or organ transplant
7. Blood transfusion within 1 month of enrollment
8. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
9. Serious medical condition that may adversely affect ability to participate in the study