Pancreatic Cyst Fluid Specimen Collection
M
Mohammad Al-Haddad, MD
Primary Investigator
Overview
Sponsor will receive de-identified leftover human pancreatic cyst fluid, which
was collected according to the clinical sites’ standard of care. Pancreatic
cysts are very common with the majority incidentally identified. There are
several types of pancreatic cysts; some types can contain cancer or have
malignant potential, whereas others are benign. However, even the types of
cysts with malignant potential rarely progress to cancer. Procedures using local site
collection processes. The planned use of these residual samples is to support the
activities of product development lifecycle testing, verification and
validation testing, on-market products support, and research studies for all
diagnostic products.
Description
The proposed multiplexed assays leverage Amplified Sciences’ proprietary reagents for
isotope-dilution, surface-enhanced Raman spectroscopy (IDSERS) to detect
multiple biomarkers on a single instrument. This innovative ultrasensitive
detection platform enables the use of a minimal
volume of cyst fluid to deliver a potential solution that both rules out
unnecessary procedures (via highly accurate mucinous vs. non-mucinous
detection) and identifies high risk malignant cysts to support surgical
intervention decisions in a simple, cost-effective laboratory operations
workflow. The quantification of low amounts of multiple biomarkers
offers a significant alternative to currently available clinical assay systems.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
biomarkers, pancreatic cyst
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- a) Patients 18 years of age or olderb) Cross sectional imaging studies demonstrating a pancreatic cyst at least 12 mm in size where fluid sampling can aid in patient’s managementc) Has the subject willingly given written consent?d) Is the subject undergoing EUS-FNA to collect pancreatic cyst fluid as a part of standa) Patients diagnosed with cancer in the past 5 years excluding skin cancer.b) Pregnant or lactating females.c) Patients with contraindications to moderate or deep procedural sedation (necessary for the conduct of the endoscopic ultrasound) like major cardiorespiratory illness.d) Patients with contraindications to fine needle aspiration of a pancreatic cyst like being on blood thinnerse) Incarcerated individuals or patients unable to provide informed consent to undergo the endoscopic ultrasound procedure.f) EUS-FNA was NOT performed during the procedureg) FNA fluid collected was less than 50 uL during procedure
- ard patient care?
Exclusion Criteria:
Updated on
03 May 2024.
Study ID: 14378; GI-AMPLIFIED-AMP101
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