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8110 Gatehouse Road, Falls Church, VA 22042

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Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer (Wadlow Signatera PDAC)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

U22-02-4671

Background Information

This study is being done to collect information about how SIGNATERA™ ctDNA testing changes how doctors make treatment recommendations to patients with early-stage pancreatic cancer. Patients with early-stage pancreatic cancer are often treated with chemotherapy, radiation, and surgery, but there is no single accepted standard of care and treatment recommendations are typically based on specific characteristics of a patient’s cancer as well as their overall health and preferences. In this study, blood will be collected for ctDNA analysis prior to and at several time points during treatment and monitoring. A recommendation for ctDNA testing is made based on medical needs and is independent of this study. The results will be available per routine care and could possibly lead to changes in treatment recommendations.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • 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
  • Additional eligibility in protocol

Ineligibility Information

  • 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
  • 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
  • Additional ineligibility in protocol