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

NCT06411470 | Recruiting

• 1 other identifier: CHEC2024-149
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Chronic Pancreatitis

Outcome Measures

Primary Outcomes (4)

• serum metabolites

  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.

  Baseline

• Gastrointestinal microbiota

  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.

  Baseline

• Overall Survival

  The length of time (in days) from study enrollment that participants remain alive.

  up to 2 years

• Predictive model

  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.

  up to 2 years

Study Arms (3)

pancreatic cancer

Pathologic diagnosis of pancreatic ductal adenocarcinoma

chronic pancreatitis

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)

healthy people

Other benign disease populations without pancreatic lesions

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

pancreatic cancer,chronic pancreatitis,healthy people

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiangyu Kong, MD

CONTACT

13564644397; xiangyukong185@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 13, 2024
• Study Start: April 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

CN (1)