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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06291779
Other study ID # SNUBH-GS- HBP5
Secondary ID E-2211-792-350 (
Status Recruiting
Phase
First received
Last updated
Start date November 30, 2022
Est. completion date May 31, 2024

Study information

Verified date February 2024
Source Seoul National University Hospital
Contact MeeYoung Kang, M.D.
Phone 82-10-5575-8881
Email rime0317@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date May 31, 2024
Est. primary completion date February 26, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
Korea, Republic of Ho-Seong Han Seongnam Gyeonggi-do

Sponsors (2)

Lead Sponsor Collaborator
Ho-Seong Han Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Urine mean concentration of purine metabolites in urine 1 day
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