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

February 26, 2024 updated by: Ho-Seong Han

Development of Pancreatic Cancer Diagnostic Method by Using a Reagent for Analyzing 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • 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.

Study Type

Observational

Enrollment (Estimated)

120

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

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Ho-Seong Han

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pancreatic cancer group: comprised patients who were scheduled for curative surgery for pancreatic cancer

Control group: The control group included healthy individuals as well as patients with benign diseases

Description

  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.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / 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 metabolite analysis reagents.
  • Compare the cutoff of the metabolic value of Pancreas cancer clarified in the existing research and the value of the sample.
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 metabolite analysis reagents.
  • Compare the cutoff of the metabolic value of Pancreas cancer clarified in the existing research and the value of the sample.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine
Time Frame: 1 day
mean concentration of purine metabolites in urine
1 day

Collaborators and Investigators

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

Sponsor

Ho-Seong Han

Collaborators

Seoul National University Bundang Hospital

Investigators

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

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Actual)

November 30, 2022

Primary Completion (Estimated)

February 26, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

January 14, 2023

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Estimated)

March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH-GS- HBP5
  • E-2211-792-350 (local IRB) (Other Identifier: Seoul National University Bundang Hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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