NCT02647177

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
May 2015Apr 2027

Study Start

First participant enrolled

May 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

11.9 years

First QC Date

January 4, 2016

Last Update Submit

August 14, 2025

Conditions

Pancreatic Cystic Lesions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Pancreatic Cyst Group

Only the eligible participant in the study are considered for inclusion in this group.

Other: Pancreatic Cyst Aspiration

Interventions

Pancreatic Cyst AspirationOTHER

10 CC of pancreatic cyst aspiration

Pancreatic Cyst Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to Memorial Hermann Hospital for care with the primary and subinvestigator(s) of the study will be identified, prescreened for eligibility and listed for informed consent and subsequent enrollment.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cyst aspirate

Study Officials

  • Nirav C Thosani, MD MHA

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Prithvi Patil, MS

CONTACT

(713) 500-6654prithvi.b.patil@uth.tmc.edu

Priyanka Priyanka, BAMS, MPH

CONTACT

7135006457priyanka.priyanka@uth.tmc.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 6, 2016

Study Start

May 1, 2015

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

August 15, 2025

Record last verified: 2025-08

Locations

US(1)