Clinical Trial 23788

• Overview

  Study Title:

  Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens (ANoPs)

  Summary:

  The goal of this clinical study is to evaluate whether the NEO-Match® test, based on ARTIDIS nanomechanical profiling technology, can help predict treatment outcomes and improve clinical decision-making in patients with suspected pancreatic cancer undergoing biopsy.

  Objective:

  Objectives: - To evaluate the value of the NEO-Match in predicting outcomes of the neoadjuvant treatment for pancreatic cancer patients. Secondary Objectives: - To evaluate the correlation of NEO-Match® with clinical outcomes for all patients. - To evaluate the correlation between NEO-Match® and treatment response to NAT based on standard imaging. - To assess how NEO-Match® correlates with the surgical success (R0 or R1 resections). - To evaluate the diagnostic accuracy of the NEO-Match® in detecting malignant pancreatic lesions, using histopathological assessment as the gold-standard. - To evaluate the correlation between molecular subtyping and the NEO-Match®. Exploratory Objectives: - To assess the feasibility of integrating the NEO-Match® platform into the standard of care workflow for pancreatic cancer diagnosis, prognosis evaluation and treatment optimization. - To correlate NEO-Match® with prognostic and/or predictive biomarkers such as morphology, tumor size, grade, proliferation, nodal status, and other potential biomarkers. - To correlate NEO-Match® with CA 19.9 levels, both at baseline and after treatment. - To correlate the NEO-Match® with treatment response (SD, PD, CR, or PR) in patients with nonresectable or advanced pancreatic cancer. - To correlate the NEO-Match® with overall response rate (CR, or PR or SD for more than 6 months) in patients with nonresectable or advanced pancreatic cancer. - To correlate observed Nanomechanical signature (NS) changes in subjects treated with neoadjuvant treatment with repeated CT/MRI imaging, to identify treatment-induced stromal and immune infiltration changes. - To identify potential treatment-associated changes in nanomechanical signature (NS) and correlate these changes with multi-dimensional molecular (including DNA mutation, gene expression, protein abundance, immune cell landscape) information from longitudinal tumor samples retrieved before, during or after treatment. - To evaluate the diagnostic accuracy of the NEO-Match® in diagnosing malignant pancreatic lesions other than pancreatic adenocarcinoma.

• Inclusion Criteria

  Inclusion Criteria:
  • Age ≥ 18 years.
  • Ability to understand and willingness to sign a written informed consent form.
  • Clinical indication for fine needle biopsy (FNB) of a suspicious pancreatic lesion accessible for biopsy.

• Exclusion Criteria

  Exclusion Criteria:
  • Any condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.