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

H

Ho-Seong Han

Status

Enrolling

Conditions

Diagnosis
Pancreas Cancer

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06291779
E-2211-792-350 (local IRB) (Other Identifier)
SNUBH-GS- HBP5

Details and patient eligibility

About

  • 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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

120 participants in 2 patient groups

Pancreatic cancer group
Description:
scheduled for curative surgery for pancreatic cancer
Treatment:
Device: Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio
Control group
Description:
group included healthy individuals as well as patients with benign diseases
Treatment:
Device: Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio

Trial contacts and locations

1

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Central trial contact

MeeYoung Kang, M.D.

Data sourced from clinicaltrials.gov

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