RecruitingNCT06291779Updated Mar 4, 2024

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

An observational study in Pancreas Cancer and Diagnosis, sponsored by Ho-Seong Han. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-04.

Sponsored by Ho-Seong Han · Observational

From the registry’s dates

Primary completion was expected by Feb 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
Started Nov 2022; still recruiting 3 years 10 months later.

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 120
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Pancreas Cancer
Diagnosis

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Keywords

Pancreatic cancer
hypoxanthine/xanthine concentration in urine

In context

Pancreatic Neoplasms

3,236 studies on the registry are indexed under Pancreatic Neoplasms; 900 are open to participants now.

This study's planned enrollment of 120 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

This is the only study on the registry with Ho-Seong Han as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
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

pancreatic cancer group

Inclusion 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

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.

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 120 participants (estimated)
Target follow-up: 5 Years
Patient registry: Yes
Biospecimen retention: Samples without dna

Groups and cohorts

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

Interventions

DevicePurine 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.

What researchers measure

Primary outcomes

Urine
mean concentration of purine metabolites in urine
Time frame: 1 day

Study locations

1 of 1 sites recruiting

Ho-Seong Han
Seongnam, Gyeonggi-do, Korea, Republic of
Recruiting

References and documents

Publications

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. PubMed 19616694 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06291779
Lead sponsor: Ho-Seong Han
Collaborators: Seoul National University Bundang Hospital
Responsible party: Ho-Seong Han (Professor, Seoul National University Hospital) — Sponsor-investigator
First posted: Mar 4, 2024
Start date: Nov 30, 2022
Primary completion: Feb 26, 2024 (estimated)
Completion: May 31, 2024 (estimated)
Last update: Mar 4, 2024

Study contacts

MeeYoung Kang, M.D.

Contact

rime0317@gmail.com

82-10-5575-8881

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

principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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