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.
| Pancreatic Cancer | Other: SIGNATERA™ ctDNA testing |
| Study Type : | Observational |
| Estimated Enrollment : | 30 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer |
| Actual Study Start Date : | August 23, 2022 |
| Estimated Primary Completion Date : | June 30, 2024 |
| Estimated Study Completion Date : | June 30, 2026 |
- Impact of SIGNATERA™ on treatment decisions [ Time Frame: 2 years ]
Examine the impact of SIGNATERA™ on treatment decisions as determined by physician questionnaires
- Frequency of positive SIGNATERA™ ctDNA testing [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 years ]
Assess patient satisfaction regarding the potential role of SIGNATERA™ ctDNA on treatment recommendations using validated questionnaires
Biospecimen Retention: Â Samples With DNA
Patients who have been diagnosed with R/BR PDAC and who have residual formalin-fixed paraffin-embedded (FFPE) tissue available will provide FFPE and whole-blood samples for SIGNATERA™ testing at baseline. Patients will provide additional whole-blood samples for SIGNATERA™ testing at months 1, 2, 4, 6, 9, 12, and 15 from the date of informed consent. The blood samples will be stored at the Inova Schar Cancer Institute and may be shared for future research.
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| Ages Eligible for Study:  | 18 Years and older  (Adult, Older Adult) |
| Sexes Eligible for Study: Â | All |
| Accepts Healthy Volunteers: Â | No |
| Sampling Method: Â | Non-Probability Sample |
participants with Resectable and Borderline Resectable Pancreatic Cancer
Inclusion Criteria:
- 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 Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05379907
| Inova Schar Cancer Institute | |
| Fairfax, Virginia, United States, 22031 | |
| Contact: Keary Janet, BS   571-472-0224   keary.janet@inova.org   | |
| Principal Investigator: Raymond Wadlow, MD Â Â Â Â Â Â | |
Inova Health Care Services
Natera, Inc.
| Principal Investigator: | Raymond Wadlow, MD | Inova Schar Cancer Institute |
| Responsible Party: | Inova Health Care Services |
| ClinicalTrials.gov Identifier: | NCT05379907 Â Â |
| Other Study ID Numbers: | U22-02-4671 |
| First Posted: | May 18, 2022 Â Â Key Record Dates |
| Last Update Posted: | October 28, 2022 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
| Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
Source: View full study details on ClinicalTrials.gov
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