Gastrointestinal Microflora and Serum Metabolomics in Patients With Pancreatic Cancer and Chronic Pancreatitis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06411470

Enrollment

600

Registered

2024-05-13

Start date

2024-04-20

Completion date

2025-12-31

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis, Pancreatic Cancer

Brief summary

The investigators plan to collect throat swabs, saliva, feces and serum samples from pancreatic cancer patients, chronic pancreatitis patients and healthy people and clarify the characteristics of oral flora and serum metabolome of pancreatic cancer patients.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

1.Pathologic diagnosis of pancreatic ductal adenocarcinoma；Diagnosis of CP defined as having obvious morphological features of CP (i.e., the presence of pancreatic calcifications on CT scan and/or magnetic resonance cholangiopancreatography)；Other benign disease populations without pancreatic lesions.

Exclusion criteria

1. Pregnant women. 2. Patients with coagulation disorders who are unable to undergo blood tests. 3. Have a history of using antibiotics or probiotics within the past 3 months.

Design outcomes

Primary

Measure	Time frame	Description
serum metabolites	Baseline	Perform Untargeted liquid chromatography-tandem mass spectrometry (LC-MS/MS) to analyse serum samples collected from pancreatic cancer patients, chronic pancreatitis patients and healthy people.
Gastrointestinal microbiota	Baseline	Perform 16S RNA sequence and shotgun metagenomic analysis of fecal, throat swabs and salivary samples collected from pancreatic cancer patients, chronic pancreatitis patients and healthy people.
Overall Survival	up to 2 years	The length of time (in days) from study enrollment that participants remain alive.
Predictive model	up to 2 years	Combined with preoperative imaging and pathological information, a predictive model of pancreatic cancer would be established based on the metabolic and microbiota difference. Verify the stability and accuracy of our model in larger cohorts and promote clinical translation.

Countries

China

Contacts

Primary ContactXiangyu Kong, MD

xiangyukong185@hotmail.com13564644397

Outcome results