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NCT Number: NCT02647177

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

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Bijun Kannadath, MBBS

CONTACT

[email protected]

713-500-6654

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Pancreatic Cystic Lesions (PCLs) or Acute Pancreatitis (AP) or chronic pancreatitis(CP) or Pancreatic 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

Treatment and study plan

Pancreatic Cyst Aspiration

Other

10 CC of pancreatic cyst aspiration

Primary outcomes

  1. Detection of early progression to Tumor

    Time frame: 2 years

    To identify any correlation between higher expression levels with early progression to malignant changes in the pancreas

Study contacts

Contact information is provided by the study sponsor or research team.

Prithvi Patil, MS

CONTACT

[email protected]

(713) 500-6654

Priyanka Priyanka, BAMS, MPH

CONTACT

[email protected]

7135006457

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Jan 6, 2016
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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