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

NCT ID: NCT06291779

Last Updated: 2024-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2024-05-31

Brief Summary

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* 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

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* 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.

Conditions

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Pancreas Cancer Diagnosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pancreatic cancer group

scheduled for curative surgery for pancreatic cancer

Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio

Intervention Type DEVICE

* 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

Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio

Intervention Type DEVICE

* 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Ho-Seong Han

OTHER

Sponsor Role lead

Responsible Party

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Ho-Seong Han

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ho-Seong Han, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Ho-Seong Han

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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MeeYoung Kang, M.D.

Role: CONTACT

82-10-5575-8881

References

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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.

Reference Type BACKGROUND
PMID: 19616694 (View on PubMed)

Other Identifiers

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E-2211-792-350 (local IRB)

Identifier Type: OTHER

Identifier Source: secondary_id

SNUBH-GS- HBP5

Identifier Type: -

Identifier Source: org_study_id

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