Clinical Trial Record

Return to Clinical Trials

Diagnosis of Pancreatic Cancer by Purine Metabolite (Hypoxanthine, Xanthine) in Urine


2022-11-30


2024-02-26


2024-05-31


120

Study Overview

Diagnosis of Pancreatic Cancer by Purine Metabolite (Hypoxanthine, Xanthine) in Urine

* This study aim to develope a diagnostic method of pancreatic cancer by using a reagent for analyzing purine metabolite (Hypoxanthine, Xanthine) in urine. * It is safe and cost effective compare to radiologic or blood test. It can be used for initial screening test for healty population.

* CubeBio and Seoul National University Bundang Hospital signed a joint technology development agreement to compare the analytical performance of existing analytical methods and purine metabolite analysis reagents developed by CubeBio. * Through quantitative analysis of hypoxanthine and xanthine in the urine of normal people and pancreatic cancer patients, we plan to confirm the possibility of diagnosing pancreatic cancer using reagents for analyzing purine metabolites. * Early diagnosis of pancreatic cancer is a key determinant of cure and survival rates, and impact on all aspects of cancer, including rate of progression, treatment, and prognosis. * This study could change the paradigm of pancreatic cancer screening by evaluating the stability and accuracy of urinary purine metabolite analysis reagents.

  • Pancreas Cancer
  • Diagnosis
  • DEVICE: Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio
  • SNUBH-GS- HBP5
  • E-2211-792-350 (local IRB) (OTHER Identifier) (OTHER: Seoul National University Bundang Hospital)

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 Results Reporting Dates Study Record Updates

2023-01-14  

N/A  

2024-02-26  

2024-02-26  

N/A  

2024-03-04  

2024-03-04  

N/A  

2024-02  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
: Pancreatic cancer group

scheduled for curative surgery for pancreatic cancer

DEVICE: Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio

  • * Collect urine from the patient to measure urinary hypoxia, xanthine concentration. * Hypoxic acid, xanthine analysis in urine using High Performance Liquid Chromatography (HPLC). * After that, hypoxanthine and xanthine will be analyzed using purine meta
: Control group

group included healthy individuals as well as patients with benign diseases

DEVICE: Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio

  • * Collect urine from the patient to measure urinary hypoxia, xanthine concentration. * Hypoxic acid, xanthine analysis in urine using High Performance Liquid Chromatography (HPLC). * After that, hypoxanthine and xanthine will be analyzed using purine meta
Primary Outcome MeasuresMeasure DescriptionTime Frame
Urinemean concentration of purine metabolites in urine1 day
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: MeeYoung Kang, M.D.

Phone Number: 82-10-5575-8881

Email: rime0317@gmail.com

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:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

    1. pancreatic cancer group
    Inclusion Criteria:
  • Pancreatic ductal adenocarcinoma that is pathologically confirmed or shows characteristic radiologic features
  • Patients with resectable pancreatic cancer at the time of surgery (Including borderline resectable pancreatic cancer at the time of diagnosis or Locally advanced pancreatic cancer after chemotherapy or radiation therapy)
  • Patients without invasion of adjacent organs other than the left adrenal gland and mesocolon
  • Patients with informed consent

  • Exclusion Criteria:
  • History of other malignancy (Inclusive if there is no evidence of recurrence after 5 years of treatment)
  • Patient with Inflammatory disease(e.g. severe pancreatitis, cholangitis)
  • Patients with underlying diseases at high risk of general anesthesia
  • Other subject whom the investigator deems inappropriate 2. control group Inclusion Criteria included healthy individuals as well as patients with benign diseases.

  • Exclusion criteria for the control group included a previous cancer diagnosis within the past five years, active inflammatory diseases, borderline malignant pancreatic tumors, or a postoperative pathological finding of malignancy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Seoul National University Bundang Hospital

  • PRINCIPAL_INVESTIGATOR: Ho-Seong Han, M.D. Ph.D., Seoul National University Bundang Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Wu H, Xue R, Dong L, Liu T, Deng C, Zeng H, Shen X. Metabolomic profiling of human urine in hepatocellular carcinoma patients using gas chromatography/mass spectrometry. Anal Chim Acta. 2009 Aug 19;648(1):98-104. doi: 10.1016/j.aca.2009.06.033. Epub 2009 Jun 21.