Pancreas CancerNCT06291779
Diagnosis of Pancreatic Cancer by Purine Metabolite (Hypoxanthine, Xanthine) in Urine
An observational study of Pancreas Cancer and Diagnosis, run by Ho-Seong Han at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreas Cancer, Diagnosis
- What is being tested?
- Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2022to 31 May 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ho-Seong Han
Seongnam-si, Gyeonggi-do
About this study
Official title: Development of Pancreatic Cancer Diagnostic Method by Using a Reagent for Analyzing Purine Metabolite (Hypoxanthine, Xanthine) in Urine
- 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
- Pancreas Cancer, Diagnosis
- Being tested
- Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio
- Keywords
- Pancreatic cancer, hypoxanthine/xanthine concentration in urine
- Medical subject headings
- Pancreatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBioDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic cancer group | scheduled for curative surgery for pancreatic cancer Receives: Device: Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio | |
| Control group | group included healthy individuals as well as patients with benign diseases Receives: Device: Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine
mean concentration of purine metabolites in urine
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start30 Nov 2022
- Primary completion26 Feb 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ho-Seong Han
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Sponsor-investigator, Ho-Seong Han, Seoul National University Hospital
- Investigators
- Ho-Seong Han, M.D. Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291779
- Sponsor's protocol ID
- SNUBH-GS- HBP5
- Other IDs
- E-2211-792-350 (local IRB)
- Status last verified
- Feb 2024
- First submitted
- 14 Jan 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Pancreatic Cancer Diagnostic Method by Using a Reagent for Analyzing Purine Metabolite (Hypoxanthine, Xanthine) in Urine
- ClinicalTrials.gov ID
- NCT06291779
- Acronym / sponsor ID
- SNUBH-GS- HBP5
- Conditions
- Pancreas Cancer, Diagnosis
- Keywords
- Pancreatic cancer, hypoxanthine/xanthine concentration in urine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ho-Seong HanUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 26 Feb 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic cancer group | – | Device: Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBioscheduled for curative surgery for pancreatic cancer |
| Control group | – | Device: Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBiogroup included healthy individuals as well as patients with benign diseases |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Control group, Pancreatic cancer group |
Primary outcome
Urine
Time frame: 1 day
mean concentration of purine metabolites in urine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Background: PubMed 19616694Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Seong Han, M.D. Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer and Diagnosis, run by Ho-Seong Han at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MeeYoung Kang, M.D. (82-10-5575-8881, rime0317@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06291779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.