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Clinical Trials/NCT06291779
NCT06291779
Recruiting
Not Applicable

Development of Pancreatic Cancer Diagnostic Method by Using a Reagent for Analyzing Purine Metabolite (Hypoxanthine, Xanthine) in Urine

Ho-Seong Han1 site in 1 country120 target enrollmentNovember 30, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreas Cancer
Sponsor
Ho-Seong Han
Enrollment
120
Locations
1
Primary Endpoint
Urine
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

  • 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.

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.

Registry
clinicaltrials.gov
Start Date
November 30, 2022
End Date
May 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ho-Seong Han
Responsible Party
Sponsor Investigator
Principal Investigator

Ho-Seong Han

Professor

Seoul National University Hospital

Eligibility Criteria

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
  • 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.

Outcomes

Primary Outcomes

Urine

Time Frame: 1 day

mean concentration of purine metabolites in urine

Study Sites (1)

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