Pancreatic CancersNCT07030348
Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study
An observational study of Pancreatic Cancers and Pancreatic Diseases, run by Do Hyun Park at 3 sites in 2 countries.
Trial summary
Purpose Pancreatic cancer is the fourth leading cancer-related mortality disease in the United States, with a five-year survival rate of 11%, and only 10 15% of all pancreatic cancer patients are operable or borderline operable. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancers, Pancreatic Diseases
- Type of treatment
- Injection or infusion
- How many people
- 263 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who require a gastro-duodenal endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography (ERCP) for medical purposes will be enrolled in this study. The pancreatic cancer group and the control non-pancreatic cancer group will be recruited.
Who may be able to join
- Among the patients requiring gastro-duodenal endoscopy, endoscopic ultrasound, or ERCP for medical purposes, the pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or 4.
- Be at least 19 years old.
- Have completed the informed consent for planned upper endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography before the duodenal fluid collection.
- A biopsy with proven stage I-IV pancreatic ductal adenocarcinoma (PDAC).
- Suspected pancreatic cancer on imaging and scheduled for an endoscopic ultrasound-guided pancreatic biopsy.
- The non-pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or 4.
Show all 10Show fewer
- Be at least 19 years old.
- Have completed the informed consent for planned upper endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography before the duodenal fluid collection.
- Patients with pancreatic cystic tumors or patients with acute or chronic pancreatitis.
- No evidence of a pancreatic disease.
Who cannot join
- The exclusion criteria for the pancreatic cancer and the non-pancreatic cancer groups will be:
- Innate or post-surgical anatomy that precludes direct sampling of duodenal fluid.
- Hemodynamically unstable and unable to have an endoscopy performed.
- A large amount of ascites fluid that is not controlled and unable to have an endoscopy performed.
- A coagulation disorder that cannot be corrected and unable to have an endoscopy performed.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
About this study
Purpose Pancreatic cancer is the fourth leading cancer-related mortality disease in the United States, with a five-year survival rate of 11%, and only 10 15% of all pancreatic cancer patients are operable or borderline operable.
Therefore, there is an unmet need for early diagnosis of pancreatic cancer; however, biomarkers related to this are not well understood. This study aims to identify biomarkers for the early diagnosis of pancreatic cancer through duodenal pancreatic juice, which can be easily obtained through an endoscopy.
Read the detailed description
Pancreatic cancer is the fourth leading cancer-related mortality disease in the United States, with a five-year survival rate of 11%, which is a very poor prognosis, and only 10-15% of all pancreatic cancer patients are operable or borderline operable.
Therefore, there is an unmet need for early diagnosis of pancreatic cancer; however, the biomarkers of humoral fluids associated with the early diagnosis of pancreatic cancer are not well understood.
Duodenal pancreatic fluids can be easily obtained through an endoscopy and contain a large amount of pancreatic fluid secreted by the pancreas, which is known to be a candidate of biomarkers for early diagnosis of pancreatic cancer.
However, there have been few studies using duodenal fluids in Korea. This study aims to prospectively analyze biomarkers for early diagnosis of pancreatic cancer using duodenal fluids obtained by endoscopy in pancreatic and non-pancreatic cancer groups.
- Conditions
- Pancreatic Cancers, Pancreatic Diseases
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Cancer Group (DP) | Participants with a biopsy with proven stage I-IV pancreatic ductal adenocarcinoma (PDAC), or with suspected pancreatic cancer on imaging and scheduled for an endoscopic ultrasound-guided pancreatic biopsy. | |
| Non-Pancreatic Cancer Group (DC) | Participants with pancreatic cystic tumors or with acute or chronic pancreatitis, or with no evidence of a pancreatic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Biomarkers for Early Pancreatic Cancer Detection
Area Under the Receiver Operating Characteristic Curve (AUC) and 95% Confidence Interval (CI) of candidate biomarkers in the training cohort. If the AUC falls within ±5% of the target value (0.94), the optimal cutoff value for pancreatic cancer differentiation will be reported using Youden's Index.
Measured: Up to 1 year from baseline
Secondary outcomes (1)
External Validation Using U.S. Samples
Area under the ROC curve (AUC) of candidate biomarkers in the U.S. validation cohort using cut-off values derived from the Korean training cohort
Measured: Up to 2 year from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start2 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancersStudies 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
- 263 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Do Hyun Park
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, University of Colorado, Denver
- Responsible party
- Sponsor-investigator, Do Hyun Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030348
- Sponsor's protocol ID
- DHP_Bio
- Other IDs
- AMC_IRB_2023-1498
- Status last verified
- Jun 2025
- First submitted
- 21 May 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study
- ClinicalTrials.gov ID
- NCT07030348
- Acronym / sponsor ID
- DHP_Bio
- Conditions
- Pancreatic Cancers, Pancreatic Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 263 participants (estimated)
- Lead sponsor
- Do Hyun ParkUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, University of Colorado, Denver
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jun 2025 (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.
Purpose Pancreatic cancer is the fourth leading cancer-related mortality disease in the United States, with a five-year survival rate of 11%, and only 10 15% of all pancreatic cancer patients are operable or borderline operable.
Therefore, there is an unmet need for early diagnosis of pancreatic cancer; however, biomarkers related to this are not well understood. This study aims to identify biomarkers for the early diagnosis of pancreatic cancer through duodenal pancreatic juice, which can be easily obtained through an endoscopy.
Detailed description
Pancreatic cancer is the fourth leading cancer-related mortality disease in the United States, with a five-year survival rate of 11%, which is a very poor prognosis, and only 10-15% of all pancreatic cancer patients are operable or borderline operable.
Therefore, there is an unmet need for early diagnosis of pancreatic cancer; however, the biomarkers of humoral fluids associated with the early diagnosis of pancreatic cancer are not well understood.
Duodenal pancreatic fluids can be easily obtained through an endoscopy and contain a large amount of pancreatic fluid secreted by the pancreas, which is known to be a candidate of biomarkers for early diagnosis of pancreatic cancer.
However, there have been few studies using duodenal fluids in Korea. This study aims to prospectively analyze biomarkers for early diagnosis of pancreatic cancer using duodenal fluids obtained by endoscopy in pancreatic and non-pancreatic cancer groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Cancer Group (DP) | – | –Participants with a biopsy with proven stage I-IV pancreatic ductal adenocarcinoma (PDAC), or with suspected pancreatic cancer on imaging and scheduled for an endoscopic ultrasound-guided pancreatic biopsy. |
| Non-Pancreatic Cancer Group (DC) | – | –Participants with pancreatic cystic tumors or with acute or chronic pancreatitis, or with no evidence of a pancreatic disease |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who require a gastro-duodenal endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography (ERCP) for medical purposes will be enrolled in this study. The pancreatic cancer group and the control non-pancreatic cancer group will be recruited.
Key inclusion criteria (10 listed)
- Among the patients requiring gastro-duodenal endoscopy, endoscopic ultrasound, or ERCP for medical purposes, the pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or 4.
- Be at least 19 years old.
- Have completed the informed consent for planned upper endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography before the duodenal fluid collection.
- A biopsy with proven stage I-IV pancreatic ductal adenocarcinoma (PDAC).
- Suspected pancreatic cancer on imaging and scheduled for an endoscopic ultrasound-guided pancreatic biopsy.
Key exclusion criteria (5 listed)
- The exclusion criteria for the pancreatic cancer and the non-pancreatic cancer groups will be:
- Innate or post-surgical anatomy that precludes direct sampling of duodenal fluid.
- Hemodynamically unstable and unable to have an endoscopy performed.
- A large amount of ascites fluid that is not controlled and unable to have an endoscopy performed.
- A coagulation disorder that cannot be corrected and unable to have an endoscopy performed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of Biomarkers for Early Pancreatic Cancer Detection
Time frame: Up to 1 year from baseline
Area Under the Receiver Operating Characteristic Curve (AUC) and 95% Confidence Interval (CI) of candidate biomarkers in the training cohort. If the AUC falls within ±5% of the target value (0.94), the optimal cutoff value for pancreatic cancer differentiation will be reported using Youden's Index.
1 secondary outcome
External Validation Using U.S. Samples
Time frame: Up to 2 year from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancers and Pancreatic Diseases, run by Do Hyun Park at 3 sites in 2 countries.
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 10 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HyeJin Song, CRC (+82-2-2045-3825, asangicrc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Biomarkers for Early Pancreatic Cancer Detection (time frame: Up to 1 year from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2025.