Clinical trial NCT06291779: Diagnosis of Pancreatic Cancer by Purine Metabolite (Hypoxanthine, Xanthine) in Urine
Official title: Development of Pancreatic Cancer Diagnostic Method by Using a Reagent for Analyzing Purine Metabolite (Hypoxanthine, Xanthine) in Urine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Cancer
Diagnosis
Keywords: Pancreatic cancer
hypoxanthine/xanthine concentration in urine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2024-03-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urine
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Ho-Seong Han
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Ho-Seong Han, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.