An observational study in Chronic Pancreatitis and Pancreatic Cancer, sponsored by Changhai Hospital. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Changhai Hospital · Observational
Among 41 studies in Pancreatitis, Chronic by Changhai Hospital — 13 open to participants now, 18 under way, none of them phase 3. Pancreatitis, Chronic · Changhai Hospital.
Among the 41 studies in Pancreatitis, Chronic by Changhai Hospital, this one is the 11th largest by planned enrollment of the 28 observational ones that give a count, is one of 3 that started in 2026, is one of 28 observational ones, reaches primary completion later than 13 of the 17 other live ones, and was the 41st registered.
264 studies on the registry are indexed under Pancreatitis, Chronic; 76 are open to participants now.
Browse Pancreatitis, Chronic studies →13 of the 41 studies in Pancreatitis, Chronic by Changhai Hospital are open now, in 1 country. Recruiting first, the newest first:
Changhai Hospital · Sites in China
Changhai Hospital · Sites in China
Changhai Hospital · Sites in China
Changhai Hospital · Sites in China
Changhai Hospital · Sites in China
By country, each count listing its studies:
Of the 49 Pancreatitis, Chronic studies recruiting now, 31 (63%) set no upper age limit and 12 (24%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 800 is above the median of 300 across 115 observational studies indexed under Pancreatitis, Chronic.
Median enrollment 134 across the 13 interventional studies, 657 across the 28 observational. Of the 15 that completed or were terminated, 1 (7%) have results posted.
This tab as a report to print or save as PDF → With an account.
Changhai Hospital is the lead sponsor of 355 studies on the registry; 137 are open to participants now.
1 of the studies in Pancreatitis, Chronic by Changhai Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03324698Changhai HospitalThe Natural History of Chronic Pancreatitis | 2026-12-31 |
Among the 41 studies in Pancreatitis, Chronic by Changhai Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
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.
Time frame: 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.
Time frame: Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol
Time frame: Beginning 12 months after publication of the main study results and available for 5 years.
Access criteria: Researchers with a scientifically sound proposal may submit a data access request to the study investigators or the designated data management platform. Requests will be reviewed for scientific purpose, ethical approval, data security, and consistency with the informed consent and institutional policies. Data will be shared only after approval and, when required, completion of a data use agreement.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2028, 28 months later.
Of 56 non-industry observational studies under Pancreatitis, Chronic, half reached primary completion within 87 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 160. This study's planned 28 months is below that.
Counting every sponsor, half of 58 studies reached it within 63 months; a quarter within 28 and three quarters within 160.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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