A Prospective Study To Identify Predictive Biological Markers In Blood And Cyst Fluid Aspirates From Patients With Pancreatic Cyst Lesions
NCT ID: NCT02647177
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2015-05-31
2027-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Pancreatic Cyst Group
Only the eligible participant in the study are considered for inclusion in this group.
Pancreatic Cyst Aspiration
10 CC of pancreatic cyst aspiration
Interventions
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Pancreatic Cyst Aspiration
10 CC of pancreatic cyst aspiration
Eligibility Criteria
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Inclusion Criteria
* 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 unable to provide informed consent
* Patients unable to complete follow up
18 Years
100 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Nirav C Thosani
Assistant Professor
Principal Investigators
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Nirav C Thosani, MD MHA
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-MS-14-0980
Identifier Type: -
Identifier Source: org_study_id
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