Chronic PancreatitisNCT07762950
Blood Biomarkers and Gut Microbiota for Pancreatic Cancer Risk in Chronic Pancreatitis
An observational study of Chronic Pancreatitis and Pancreatic Cancer, run by Changhai Hospital.
Trial summary
The goal of this observational study is to learn more about pancreatic cancer risk in people with chronic pancreatitis. Researchers will study blood markers and gut microorganisms, which are bacteria and other microbes living in the intestine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis, Pancreatic Cancer
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2028
- How long will I take part?
- 28 Months
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be selected from healthy volunteers and patients receiving care at Changhai Hospital. The study population will include healthy controls, patients with chronic pancreatitis, and patients with newly diagnosed pancreatic ductal adenocarcinoma. Patients with chronic pancreatitis and pancreatic ductal adenocarcinoma will be identified through outpatient clinics, inpatient wards, and routine clinical evaluation. Healthy volunteers will be recruited as a reference cohort. Participants will be recruited using a non-probability sampling approach from outpatient clinics, inpatient wards, and healthy volunteer sources at Changhai Hospital.
Who may be able to join
- Adults aged 18 years or older.
- Able to understand the study procedures and provide written informed consent.
- Healthy controls: participants without a known history of chronic pancreatitis or pancreatic cancer.
- Chronic pancreatitis cohort: participants diagnosed with chronic pancreatitis according to clinical guidelines, based on clinical, imaging, and/or genetic information.
- Pancreatic ductal adenocarcinoma cohort: participants with newly diagnosed pancreatic ductal adenocarcinoma based on clinical, imaging, and/or pathological evaluation.
- Willing to provide blood samples and relevant clinical information.
- For participants with chronic pancreatitis, willing to undergo longitudinal follow-up approximately every 6 to 12 months.
Who cannot join
- Unable or unwilling to provide written informed consent.
- Unable to provide required clinical information or biological samples.
- Prior diagnosis of another active malignant tumor, except adequately treated non-melanoma skin cancer or carcinoma in situ, if considered not to affect study participation by the investigator.
- Current severe acute infection or other serious medical condition that, in the investigator's judgment, may interfere with study participation or interpretation of immune-related analyses.
- Use of systemic immunosuppressive therapy or immunotherapy within a period considered clinically relevant by the investigator.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immune Repertoire Decoding Enables Dynamic Risk Stratification During Chronic Pancreatitis-to-Pancreatic Cancer Transition
The goal of this observational study is to learn more about pancreatic cancer risk in people with chronic pancreatitis. Researchers will study blood markers and gut microorganisms, which are bacteria and other microbes living in the intestine.
Researchers will compare healthy participants, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic cancer. The study will examine whether blood markers and gut microorganisms differ among these groups. It will also study how these features change over time and whether they may help identify people with chronic pancreatitis who are at higher risk of pancreatic cancer.
Read more
Participants will provide blood and stool samples. Researchers will also collect health information, laboratory test results, and abdominal scan results. Participants with chronic pancreatitis will be followed about every 6 to 12 months. Participants with pancreatic cancer will also be followed according to their routine medical care schedule. Researchers will collect information about their treatment, disease changes, test results, scans, and survival status.
Some participants with chronic pancreatitis or pancreatic cancer may be asked to provide additional blood or stool samples. Their permission will be confirmed before each additional sample is collected. Refusing an additional sample will not affect their routine medical care or continued follow-up in the study.
No treatment will be assigned as part of this study. The findings may help improve future methods for assessing pancreatic cancer risk in people with chronic pancreatitis.
Read the detailed description
Chronic pancreatitis is associated with an increased risk of pancreatic ductal adenocarcinoma, but the biological changes that occur during disease progression remain incompletely understood. Changes in circulating inflammatory and immune-related biomarkers, disruption of the gut microbiota, and the movement of microbial products from the intestine into the bloodstream may reflect interactions among chronic inflammation, gut microbial imbalance, and impaired immune surveillance.
This is a single-center, prospective observational cohort study conducted at Changhai Hospital. The study plans to enroll up to 800 participants, including 200 healthy controls, 300 participants with chronic pancreatitis, and 300 patients with newly diagnosed pancreatic ductal adenocarcinoma. Healthy controls will serve as a reference group. Participants with chronic pancreatitis will form the main longitudinal cohort, and patients with pancreatic ductal adenocarcinoma will serve as the pancreatic cancer comparison cohort.
At baseline, participants will provide peripheral blood and fresh stool samples. Blood samples will be used to measure inflammatory, immune-related, and tumor-associated biomarkers, including CXCL10 (IP-10), GLYR1, TGF-beta, Artemin, and other candidate biomarkers. Markers related to gut barrier dysfunction and the movement of microbial products into the circulation, such as lipopolysaccharide, endotoxin-related measures, and soluble CD14, may also be assessed.
Stool samples will be analyzed using 16S ribosomal RNA gene sequencing, metagenomic sequencing, and related microbiome analysis methods. These analyses will characterize microbial diversity, taxonomic composition, functional pathways, and selected microbial metabolites, including pathways related to short-chain fatty acids and bile acids. Whenever feasible, blood and stool samples collected at the same time point will be analyzed as paired samples to investigate associations between circulating biomarkers and gut microbiota features.
Participants with chronic pancreatitis will generally be followed every 6 to 12 months. Follow-up may occur earlier or more frequently if there are changes in the participant's condition, an acute episode, imaging progression, an important treatment, or another clinical reason for evaluation. Follow-up information will include treatment, changes in disease status, laboratory test results, abdominal imaging findings, and relevant clinical outcomes.
Patients with pancreatic ductal adenocarcinoma will also be followed after enrollment according to their routine clinical care and follow-up schedule. Follow-up will be conducted through review of electronic medical records, outpatient or inpatient visits, and telephone contact when necessary. Information collected will include subsequent treatment, disease progression, recurrence or metastasis, laboratory and imaging results, survival status, and other relevant outcomes. Follow-up will continue until the end of the study, withdrawal from the study, or death.
Biological samples will not be routinely collected at every follow-up visit. Additional blood or stool samples may be collected from selected participants with chronic pancreatitis or pancreatic ductal adenocarcinoma when considered appropriate by the investigators or when participants express a willingness to provide additional samples. Before each additional sample collection, the participant's voluntary agreement will be reconfirmed. Refusal to provide an additional sample will not affect continued information follow-up or routine medical care. No research tissue samples will be collected from patients with pancreatic ductal adenocarcinoma during follow-up, and the study will not require additional imaging examinations, treatment, or invasive tissue sampling solely for research purposes.
Clinical information, laboratory results, abdominal computed tomography or magnetic resonance imaging data, and selected genetic information will also be collected when available. The main analyses will compare blood biomarker concentrations, gut microbiota diversity, microbial composition, and microbial functional features among the three groups. Longitudinal analyses will evaluate changes over time and their associations with clinical outcomes in participants with chronic pancreatitis and pancreatic ductal adenocarcinoma.
Candidate blood biomarkers and microbiota-derived features will be integrated with available immune-related, clinical, imaging, and genetic data. The study will develop and internally evaluate a multimodal model for pancreatic cancer risk stratification in participants with chronic pancreatitis. Model performance will be assessed using measures of discrimination, calibration, sensitivity, specificity, and clinical utility. No study treatment, experimental drug, or experimental medical device will be assigned to participants.
- Conditions
- Chronic Pancreatitis, Pancreatic Cancer
- Keywords
- Pancreatic Ductal Adenocarcinoma, Serum Biomarkers, Gut Microbiota, Microbial Translocation, Risk Stratification
- Medical subject headings
- Pancreatitis, Chronic, Pancreatic Neoplasms
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 |
|---|---|---|
| Healthy Controls | Healthy volunteers without chronic pancreatitis or pancreatic cancer will be enrolled as the reference cohort for comparison with the chronic pancreatitis and pancreatic ductal adenocarcinoma cohorts. | |
| Chronic Pancreatitis | Participants with chronic pancreatitis will be enrolled as the main longitudinal cohort. This cohort will be followed over time to evaluate clinical, imaging, genetic, and immune features associated with pancreatic cancer risk. | |
| Pancreatic Ductal Adenocarcinoma | Participants with newly diagnosed pancreatic ductal adenocarcinoma will be enrolled as the pancreatic cancer cohort for comparison with the healthy control and chronic pancreatitis cohorts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum or Plasma CXCL10 (IP-10) Concentration
CXCL10 (IP-10) concentration will be measured in serum or plasma using a prespecified laboratory assay. Baseline concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up.
Measured: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
Serum or Plasma GLYR1 Concentration
GLYR1 concentration will be measured in serum or plasma using a prespecified laboratory assay. Baseline concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up.
Measured: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
Serum or Plasma TGF-beta Concentration
TGF-beta concentration will be measured in serum or plasma using a prespecified laboratory assay. Baseline concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up.
Measured: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
Serum or Plasma Artemin Concentration
Artemin concentration will be measured in serum or plasma using a prespecified laboratory assay. Baseline concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up.
Measured: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
Gut Microbiota Shannon Diversity Index
The Shannon diversity index will be calculated from stool microbiome data generated using 16S ribosomal RNA gene sequencing and/or metagenomic sequencing. Baseline Shannon diversity will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will be evaluated in participants who provide repeat stool samples during follow-up.
Measured: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
Gut Microbiota Simpson Diversity Index
The Simpson diversity index will be calculated from stool microbiome data generated using 16S ribosomal RNA gene sequencing and/or metagenomic sequencing. Baseline Simpson diversity will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will be evaluated in participants who provide repeat stool samples during follow-up.
Measured: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
Secondary outcomes (2)
Serum Lipopolysaccharide (LPS) Concentration
Serum lipopolysaccharide (LPS) concentration will be measured using a prespecified laboratory assay as a marker of microbial translocation. Baseline LPS concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up. LPS will be reported using the concentration unit specified by the assay.
Measured: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
Serum Soluble CD14 (sCD14) Concentration
Serum soluble CD14 (sCD14) concentration will be measured using a prespecified laboratory assay as a marker associated with microbial translocation and gut-immune interactions. Baseline sCD14 concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up. sCD14 will be reported using the concentration unit specified by the assay.
Measured: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai 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
- 800 participants (estimated)
- Target duration
- 28 Months
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhuan Liao, PhD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762950
- Sponsor's protocol ID
- CHEC2026-289
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the main study results may be shared under controlled access. Shared data may include demographic and clinical variables, laboratory results, longitudinal follow-up outcomes, serum biomarker measurements, including CXCL10 (IP-10), GLYR1, TGF-beta, and Artemin, gut microbiota-derived data or processed features, microbial translocation markers, imaging-derived variables or metadata, and selected genetic results. A data dictionary and relevant metadata will be provided when applicable. Data sharing will be limited to information permitted by the ethics approval, informed consent, applicable regulations, and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Repertoire Decoding Enables Dynamic Risk Stratification During Chronic Pancreatitis-to-Pancreatic Cancer Transition
- ClinicalTrials.gov ID
- NCT07762950
- Acronym / sponsor ID
- CHEC2026-289
- Conditions
- Chronic Pancreatitis, Pancreatic Cancer
- Keywords
- Pancreatic Ductal Adenocarcinoma, Serum Biomarkers, Gut Microbiota, Microbial Translocation, Risk Stratification
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Aug 2026 (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.
The goal of this observational study is to learn more about pancreatic cancer risk in people with chronic pancreatitis. Researchers will study blood markers and gut microorganisms, which are bacteria and other microbes living in the intestine.
Researchers will compare healthy participants, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic cancer. The study will examine whether blood markers and gut microorganisms differ among these groups. It will also study how these features change over time and whether they may help identify people with chronic pancreatitis who are at higher risk of pancreatic cancer.
Participants will provide blood and stool samples. Researchers will also collect health information, laboratory test results, and abdominal scan results. Participants with chronic pancreatitis will be followed about every 6 to 12 months. Participants with pancreatic cancer will also be followed according to their routine medical care schedule. Researchers will collect information about their treatment, disease changes, test results, scans, and survival status.
Some participants with chronic pancreatitis or pancreatic cancer may be asked to provide additional blood or stool samples. Their permission will be confirmed before each additional sample is collected. Refusing an additional sample will not affect their routine medical care or continued follow-up in the study.
No treatment will be assigned as part of this study. The findings may help improve future methods for assessing pancreatic cancer risk in people with chronic pancreatitis.
Detailed description
Chronic pancreatitis is associated with an increased risk of pancreatic ductal adenocarcinoma, but the biological changes that occur during disease progression remain incompletely understood. Changes in circulating inflammatory and immune-related biomarkers, disruption of the gut microbiota, and the movement of microbial products from the intestine into the bloodstream may reflect interactions among chronic inflammation, gut microbial imbalance, and impaired immune surveillance.
This is a single-center, prospective observational cohort study conducted at Changhai Hospital. The study plans to enroll up to 800 participants, including 200 healthy controls, 300 participants with chronic pancreatitis, and 300 patients with newly diagnosed pancreatic ductal adenocarcinoma. Healthy controls will serve as a reference group. Participants with chronic pancreatitis will form the main longitudinal cohort, and patients with pancreatic ductal adenocarcinoma will serve as the pancreatic cancer comparison cohort.
At baseline, participants will provide peripheral blood and fresh stool samples. Blood samples will be used to measure inflammatory, immune-related, and tumor-associated biomarkers, including CXCL10 (IP-10), GLYR1, TGF-beta, Artemin, and other candidate biomarkers. Markers related to gut barrier dysfunction and the movement of microbial products into the circulation, such as lipopolysaccharide, endotoxin-related measures, and soluble CD14, may also be assessed.
Stool samples will be analyzed using 16S ribosomal RNA gene sequencing, metagenomic sequencing, and related microbiome analysis methods. These analyses will characterize microbial diversity, taxonomic composition, functional pathways, and selected microbial metabolites, including pathways related to short-chain fatty acids and bile acids. Whenever feasible, blood and stool samples collected at the same time point will be analyzed as paired samples to investigate associations between circulating biomarkers and gut microbiota features.
Participants with chronic pancreatitis will generally be followed every 6 to 12 months. Follow-up may occur earlier or more frequently if there are changes in the participant's condition, an acute episode, imaging progression, an important treatment, or another clinical reason for evaluation. Follow-up information will include treatment, changes in disease status, laboratory test results, abdominal imaging findings, and relevant clinical outcomes.
Patients with pancreatic ductal adenocarcinoma will also be followed after enrollment according to their routine clinical care and follow-up schedule. Follow-up will be conducted through review of electronic medical records, outpatient or inpatient visits, and telephone contact when necessary. Information collected will include subsequent treatment, disease progression, recurrence or metastasis, laboratory and imaging results, survival status, and other relevant outcomes. Follow-up will continue until the end of the study, withdrawal from the study, or death.
Biological samples will not be routinely collected at every follow-up visit. Additional blood or stool samples may be collected from selected participants with chronic pancreatitis or pancreatic ductal adenocarcinoma when considered appropriate by the investigators or when participants express a willingness to provide additional samples. Before each additional sample collection, the participant's voluntary agreement will be reconfirmed. Refusal to provide an additional sample will not affect continued information follow-up or routine medical care. No research tissue samples will be collected from patients with pancreatic ductal adenocarcinoma during follow-up, and the study will not require additional imaging examinations, treatment, or invasive tissue sampling solely for research purposes.
Clinical information, laboratory results, abdominal computed tomography or magnetic resonance imaging data, and selected genetic information will also be collected when available. The main analyses will compare blood biomarker concentrations, gut microbiota diversity, microbial composition, and microbial functional features among the three groups. Longitudinal analyses will evaluate changes over time and their associations with clinical outcomes in participants with chronic pancreatitis and pancreatic ductal adenocarcinoma.
Candidate blood biomarkers and microbiota-derived features will be integrated with available immune-related, clinical, imaging, and genetic data. The study will develop and internally evaluate a multimodal model for pancreatic cancer risk stratification in participants with chronic pancreatitis. Model performance will be assessed using measures of discrimination, calibration, sensitivity, specificity, and clinical utility. No study treatment, experimental drug, or experimental medical device will be assigned to participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –Healthy volunteers without chronic pancreatitis or pancreatic cancer will be enrolled as the reference cohort for comparison with the chronic pancreatitis and pancreatic ductal adenocarcinoma cohorts. |
| Chronic Pancreatitis | – | –Participants with chronic pancreatitis will be enrolled as the main longitudinal cohort. This cohort will be followed over time to evaluate clinical, imaging, genetic, and immune features associated with pancreatic cancer risk. |
| Pancreatic Ductal Adenocarcinoma | – | –Participants with newly diagnosed pancreatic ductal adenocarcinoma will be enrolled as the pancreatic cancer cohort for comparison with the healthy control and chronic pancreatitis cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from healthy volunteers and patients receiving care at Changhai Hospital. The study population will include healthy controls, patients with chronic pancreatitis, and patients with newly diagnosed pancreatic ductal adenocarcinoma. Patients with chronic pancreatitis and pancreatic ductal adenocarcinoma will be identified through outpatient clinics, inpatient wards, and routine clinical evaluation. Healthy volunteers will be recruited as a reference cohort. Participants will be recruited using a non-probability sampling approach from outpatient clinics, inpatient wards, and healthy volunteer sources at Changhai Hospital.
Key inclusion criteria (7 listed)
- Adults aged 18 years or older.
- Able to understand the study procedures and provide written informed consent.
- Healthy controls: participants without a known history of chronic pancreatitis or pancreatic cancer.
- Chronic pancreatitis cohort: participants diagnosed with chronic pancreatitis according to clinical guidelines, based on clinical, imaging, and/or genetic information.
- Pancreatic ductal adenocarcinoma cohort: participants with newly diagnosed pancreatic ductal adenocarcinoma based on clinical, imaging, and/or pathological evaluation.
Key exclusion criteria (6 listed)
- Unable or unwilling to provide written informed consent.
- Unable to provide required clinical information or biological samples.
- Prior diagnosis of another active malignant tumor, except adequately treated non-melanoma skin cancer or carcinoma in situ, if considered not to affect study participation by the investigator.
- Current severe acute infection or other serious medical condition that, in the investigator's judgment, may interfere with study participation or interpretation of immune-related analyses.
- Use of systemic immunosuppressive therapy or immunotherapy within a period considered clinically relevant by the investigator.
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
Serum or Plasma CXCL10 (IP-10) Concentration
Time frame: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
CXCL10 (IP-10) concentration will be measured in serum or plasma using a prespecified laboratory assay. Baseline concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up.
Serum or Plasma GLYR1 Concentration
Time frame: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
GLYR1 concentration will be measured in serum or plasma using a prespecified laboratory assay. Baseline concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up.
Serum or Plasma TGF-beta Concentration
Time frame: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
TGF-beta concentration will be measured in serum or plasma using a prespecified laboratory assay. Baseline concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up.
Serum or Plasma Artemin Concentration
Time frame: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
Artemin concentration will be measured in serum or plasma using a prespecified laboratory assay. Baseline concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up.
Gut Microbiota Shannon Diversity Index
Time frame: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
The Shannon diversity index will be calculated from stool microbiome data generated using 16S ribosomal RNA gene sequencing and/or metagenomic sequencing. Baseline Shannon diversity will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will be evaluated in participants who provide repeat stool samples during follow-up.
Gut Microbiota Simpson Diversity Index
Time frame: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
The Simpson diversity index will be calculated from stool microbiome data generated using 16S ribosomal RNA gene sequencing and/or metagenomic sequencing. Baseline Simpson diversity will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will be evaluated in participants who provide repeat stool samples during follow-up.
2 secondary outcomes
Serum Lipopolysaccharide (LPS) Concentration
Time frame: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
Serum Soluble CD14 (sCD14) Concentration
Time frame: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
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 13 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the main study results may be shared under controlled access. Shared data may include demographic and clinical variables, laboratory results, longitudinal follow-up outcomes, serum biomarker measurements, including CXCL10 (IP-10), GLYR1, TGF-beta, and Artemin, gut microbiota-derived data or processed features, microbial translocation markers, imaging-derived variables or metadata, and selected genetic results. A data dictionary and relevant metadata will be provided when applicable. Data sharing will be limited to information permitted by the ethics approval, informed consent, applicable regulations, and institutional policies.
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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.
Zhuan Liao, PhD principal investigator
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis and Pancreatic Cancer, run by Changhai Hospital.
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 7 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: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Zhuan Liao, PhD (+86-21-31161001, zhuanleo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum or Plasma CXCL10 (IP-10) Concentration (time frame: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment). The study lists 6 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 13 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.