RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2015-05
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02647177

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Any combination of the diagnoses above.
  3. * Patients must provide written informed consent for the collection of blood specimens for research purposes.
  4. * Patients with PCLs must provide informed consent for collection of excess cyst fluid aspirate remaining after testing for routine standard of care
  5. * 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
  1. * Patients with co-existing malignancies of other organs (or prior history of such)
  2. * Patients unable to provide informed consent
  3. * Patients unable to complete follow up

Contacts and Locations

Study Contact

Prithvi Patil, MS
CONTACT
(713) 500-6654
prithvi.b.patil@uth.tmc.edu
Priyanka Priyanka, BAMS, MPH
CONTACT
7135006457
priyanka.priyanka@uth.tmc.edu

Principal Investigator

Nirav C Thosani, MD MHA
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Nirav C Thosani, MD MHA, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-05
Study Completion Date2027-04

Study Record Updates

Study Start Date2015-05
Study Completion Date2027-04

Terms related to this study

Additional Relevant MeSH Terms

  • Pancreatic Cystic Lesions