Pancreatic Cancer
Conditions
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 patients with pancreatic cancer.
Interventions
OTHERSIGNATERA™ ctDNA testing
Information collection about how SIGNATERA™ ctDNA testing changes how doctors make treatment recommendations to patients with early-stage pancreatic cancer.
Sponsors
Natera, Inc.
Inova Health Care Services
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of SIGNATERA™ on treatment decisions | 2 years | Examine the impact of SIGNATERA™ on treatment decisions as determined by physician questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of positive SIGNATERA™ ctDNA testing | 2 years | Determine the frequency of positive SIGNATERA™ ctDNA testing in patients with R/BR PDAC at baseline and after surgical resection |
| Overall survival of patients managed with SIGNATERA™ ctDNA data | 2 years | Compare overall survival of patients managed with available SIGNATERA™ ctDNA data to historical controls |
| Progression-free survival of patients managed with SIGNATERA™ ctDNA data | 2 years | Compare progression-free survival of patients managed with available SIGNATERA™ ctDNA data to historical controls |
| Patient satisfaction of SIGNATERA™ ctDNA on treatment recommendations | 2 years | Assess patient satisfaction regarding the potential role of SIGNATERA™ ctDNA on treatment recommendations using validated questionnaires |
Countries
United States
Outcome results
None listed