A Prospective Study To Identify Predictive Biological Markers In Blood And Cyst Fluid Aspirates From Patients With Pancreatic Cyst Lesions



Status:Recruiting
Healthy:No
Age Range:18 - 100
Updated:8/15/2018
Start Date:May 2015
End Date:April 2027
Contact:Prithvi Patil, MS
Email:prithvi.b.patil@uth.tmc.edu
Phone:(713) 500-6654

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The purpose To determine the diagnostic potential of various biological markers in blood and
cyst fluid aspirates from patients with Pancreatic Cystic Lesions (PCLs).

Research design This is a 10-year prospective cohort and pancreatic cyst fluid repository
study enrolling all patients diagnosed with pancreatic cyst and undergoing the cyst
aspiration.

Procedures to be used Blood Sample Cyst Fluid Sample

Data Collection:

Medical Record Number Demographics (age, sex, gender, race) Contact information History of
alcohol use and IV and other recreational drugs and narcotics use/abuse Medication history
Past hospitalizations, diagnoses, and treatment Physical examination findings Imaging data of
abdominal and chest regions, including and not limited to ultrasonography, magnetic resonance
imaging (MRI), computed tomography (CT) Future admissions, diagnoses, treatment including
histopathological findings of resected specimens and blood reports End of study data:
clinical progression of disease, cyst size, wall thickening, calcification, communication
with pancreatic duct, string sign, cytology, immunohistochemical findings, assay levels of
lipase, amylase CEA (carcinoembryonic antigen), carbohydrate antigen19-9 (CA 19-9), and other
biomarkers.

Risks and potential benefits The risks associated with this study are slight discomfort or
bruising from the blood sampling and the possible loss of confidentiality if the patient data
or information is inadvertently disclosed outside of this study. The patient will not receive
any additional benefit from the study aside from those received as part of routine standard
of care.

Importance of knowledge that may reasonably be expected to result The knowledge gained from
this study may benefit other patients with Pancreatic Cyst Lesions in the future.


Inclusion Criteria:

- Diagnosis of Pancreatic Cystic Lesions (PCLs) or Acute Pancreatitis (AP) or chronic
pancreatitis(CP) or Pacreatic Cancer (PC) (any stage/grade) or congenital
developmental anomalies of the pancreas.

- Any combination of the diagnoses above.

- Patients must provide written informed consent for the collection of blood specimens
for research purposes.

- Patients with PCLs must provide informed consent for collection of excess cyst fluid
aspirate remaining after testing for routine standard of care

- Patients with pancreatic Cystic Lesions (PCLs) or AP or CP or PC (any stage/grade) or
congenital developmental anomalies of the pancreas undergoing surgery must provide
informed consent for collection of surgical specimen

Exclusion Criteria:

- Patients with co-existing malignancies of other organs (or prior history of such)

- Patients unable to provide informed consent

- Patients unable to complete follow up
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Phone: 713-500-6654
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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from
Houston, TX
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