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

Pancreatic Cystic Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02647177
• Other study ID #: HSC-MS-14-0980
• Status: Recruiting
• Start date: May 2015
• Est. completion date: April 2027

Study information

• Verified date: May 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Prithvi Patil, MS
• Phone: (713) 500-6654
• Email: prithvi.b.patil[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cyst
• Pancreatic Cystic Lesions

Intervention

Other:
• Pancreatic Cyst Aspiration
10 CC of pancreatic cyst aspiration

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of early progression to Tumor	To identify any correlation between higher expression levels with early progression to malignant changes in the pancreas	2 years