Pancreatic CancerNCT05596370
Association Between Cell-free Nucleic Acid in Blood, Urine and Microbiome in Stool With Pancreatobiliary Cancer
An observational study of Pancreatic Cancer and Cholangiocarcinoma, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
Based on the cell free nucleic acid analysis information of blood samples, the results of microbiome and metabolite analysis of stool and urine samples of pancreatic cancer and bile duct cancer patients, the clinical correlations of them with primary cancer are evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer, Cholangiocarcinoma, Gallbladder Cancer
- What is being tested?
- cell free DNA in blood and urine, metabolite/microbiome in urine and stool
- How many people
- 150 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 6 Jan 2022to 31 Dec 2024
- How long will I take part?
- 3 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18 or older, who diagnosed with pancreatic cancer or biliary tract cancer (cholangiocarcinoma, gallbladder cancer) through histological or radiologic examination and before treatment begins
Who may be able to join
- Patients diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins
- Patients diagnosed with biliary tract cancer (cholangiocarcinoma, gallbladder cancer) through histological or radiologic examination and before treatment begins
- Patients aged 18 or older who voluntarily agrees to participate in the study and is willing to understand and comply with the subsequent treatment procedures and sample collection schedule
Who cannot join
- Where the subject himself/herself refuses to fill out the consent form or is unable to fill out the consent form
- In the case where the sample storage conditions suggested by the reagent manufacturer are not satisfied
- Only samples that can cause errors when determining results are acquired:
- Heat treated specimen
- Incompletely coagulated serum and bacterial samples ③ Samples with particulate matter elements (e.g., fibroblasts, red blood cells) remaining in the sample
- ④ Specimens previously frozen and stored with blood clots that have confirmed an increase in non-specific reactivity in which samples appear to have denatured during storage
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- ⑤ Sample from deceased patient
- ⑥ A patient specimen with a malignancy of ohter site
- ⑦ Sample from vulnerable persons such as pregnant women, minors, etc
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 101
Sang Hyub Lee, MD PhD, 01087036267, gidoctor@snu.ac.kr
Sang Hyub Lee, MD PhD
- Recruiting
Sang Hyub Lee
Seoul
Sang Hyub Lee, MD., PhD, +82-2-2072-2228, gidoctor@snu.ac.kr
Jin Ho Choi, MD
About this study
Official title: Confirmation of Association Between Cell-free Nucleic Acid in Blood and Urine Samples and Microbiome in Stool With Pancreatobiliary Cancer and Study Related to Exploration of Biomarkers in Diagnosis and Treatment of Pancreatobiliary Cancers
Based on the cell free nucleic acid analysis information of blood samples, the results of microbiome and metabolite analysis of stool and urine samples of pancreatic cancer and bile duct cancer patients, the clinical correlations of them with primary cancer are evaluated. And based on these information, biomarkers for diagnosis, treatment, and prognosis of pancreatic and bile duct cancer are explored.
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Being tested
- cell free DNA in blood and urine, metabolite/microbiome in urine and stool
- Keywords
- cell-free nucleic acid, microbiome, biomarker
- Medical subject headings
- Pancreatic Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell free DNA in blood and urine, metabolite/microbiome in urine and stoolDiagnostic test
cell free DNA in blood and urine, metabolite/microbiome in urine and stool
| Study group | Role | What they receive |
|---|---|---|
| biliary cancer | cholangiocarcinoma gallbladder cancer Receives: Diagnostic Test: cell free DNA in blood and urine, metabolite/microbiome in urine and stool | |
| pancreatic tumor | pancreatic cancer pancreatic ductal adenocarcinoma pancreatic neuroendocrine tumor Receives: Diagnostic Test: cell free DNA in blood and urine, metabolite/microbiome in urine and stool |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of genetic mutation
concordance of genetic mutation between tissue and blood of treatment-naive status
Measured: the day of study enrollment or the day of tissue and blood acquisition
correlation of genetic mutation burden and prognosis
correlation of genetic mutation burden and prognosis
Measured: the day of study enrollment and follow-up till end of the study
Secondary outcomes (2)
correlation of metabolic change in urine metabolite and prognosis
analysis of correlation of metabolic change in urine metabolite and prognosis
Measured: the day of study enrollment and follow-up till end of the study
correlation of microbiome in stool and prognosis
analysis of correlation of microbiome in stool and prognosis
Measured: the day of study enrollment and follow-up till end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start6 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DXOME CO., LTD.
- Responsible party
- Principal investigator, Sang Hyub Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596370
- Sponsor's protocol ID
- H-2111-199-1281
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmation of Association Between Cell-free Nucleic Acid in Blood and Urine Samples and Microbiome in Stool With Pancreatobiliary Cancer and Study Related to Exploration of Biomarkers in Diagnosis and Treatment of Pancreatobiliary Cancers
- ClinicalTrials.gov ID
- NCT05596370
- Acronym / sponsor ID
- H-2111-199-1281
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Keywords
- cell-free nucleic acid, microbiome, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- DXOME CO., LTD.
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Oct 2022 (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.
Based on the cell free nucleic acid analysis information of blood samples, the results of microbiome and metabolite analysis of stool and urine samples of pancreatic cancer and bile duct cancer patients, the clinical correlations of them with primary cancer are evaluated. And based on these information, biomarkers for diagnosis, treatment, and prognosis of pancreatic and bile duct cancer are explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biliary cancer | – | Diagnostic Test: cell free DNA in blood and urine, metabolite/microbiome in urine and stoolcholangiocarcinoma gallbladder cancer |
| pancreatic tumor | – | Diagnostic Test: cell free DNA in blood and urine, metabolite/microbiome in urine and stoolpancreatic cancer pancreatic ductal adenocarcinoma pancreatic neuroendocrine tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 or older, who diagnosed with pancreatic cancer or biliary tract cancer (cholangiocarcinoma, gallbladder cancer) through histological or radiologic examination and before treatment begins
Key inclusion criteria (3 listed)
- Patients diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins
- Patients diagnosed with biliary tract cancer (cholangiocarcinoma, gallbladder cancer) through histological or radiologic examination and before treatment begins
- Patients aged 18 or older who voluntarily agrees to participate in the study and is willing to understand and comply with the subsequent treatment procedures and sample collection schedule
Key exclusion criteria (9 listed)
- Where the subject himself/herself refuses to fill out the consent form or is unable to fill out the consent form
- In the case where the sample storage conditions suggested by the reagent manufacturer are not satisfied
- Only samples that can cause errors when determining results are acquired:
- ④ Specimens previously frozen and stored with blood clots that have confirmed an increase in non-specific reactivity in which samples appear to have denatured during storage
- ⑤ Sample from deceased patient
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 |
|---|---|---|
| cell free DNA in blood and urine, metabolite/microbiome in urine and stoolcell free DNA in blood and urine, metabolite/microbiome in urine and stool | Diagnostic test | biliary cancer, pancreatic tumor |
Primary outcome
correlation of genetic mutation
Time frame: the day of study enrollment or the day of tissue and blood acquisition
concordance of genetic mutation between tissue and blood of treatment-naive status
correlation of genetic mutation burden and prognosis
Time frame: the day of study enrollment and follow-up till end of the study
correlation of genetic mutation burden and prognosis
2 secondary outcomes
correlation of metabolic change in urine metabolite and prognosis
Time frame: the day of study enrollment and follow-up till end of the study
correlation of microbiome in stool and prognosis
Time frame: the day of study enrollment and follow-up till end of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- 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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Cholangiocarcinoma, run by Seoul National University Hospital at 2 sites 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 3 inclusion and 9 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 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of genetic mutation (time frame: the day of study enrollment or the day of tissue and blood acquisition). The study lists 2 primary outcomes in all. 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 7 Nov 2022.