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

Recruiting

• Conditions: Pancreas Cancer; Diagnosis

• Registration Number: NCT06291779
• Lead Sponsor: Ho-Seong Han

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.

Study Timeline

• Study Start: 2022-11-30
• Study First Submitted: 2023-01-14
• Status Verified: 2024-02
• Primary Completion: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urine	1 day	mean concentration of purine metabolites in urine

Trial Locations

Locations (1)

Ho-Seong Han; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of