Fecal and Oral Microbiota Between Pancreatic Cancer and Benign/Low-grade Malignant Tumor Patients

NCT06659237 | Completed

• 1 other identifier: PUMCH-PCAMICROBE-2
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

Significant gaps exist in understanding the gastrointestinal microbiota in patients with pancreatic cancer (PCA) versus benign or low-grade malignant pancreatic tumors (NPCA). This study aimed to analyze these microbiota characteristics and explore their potential use in distinguishing malignant pancreatic lesions.

Conditions

Microbiome; Pancreatic Neoplasms; 16s RRNA

Keywords

fecal microbiome; oral microbiome; pancreatic neoplasms; 16s rRNA

Outcome Measures

Primary Outcomes (1)

• the accuracy of the diagnostic classifier

  we used random forest algorithm to construct oral and fecal microbiome classifiers to discriminate PCA and NPCA. AUC value was used to evaluate the efficacy of the classifiers

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Pancreatic cancer

Patients pathologically diagnosed with cancer or high-grade mucinous tumors based on surgical specimens or puncture samples

Diagnostic Test: 16s rRNA or shotgun metagenomics

Benign or low-grade malignant pancreatic tumor

Patients with pathological diagnoses such as low-grade intraductal papillary mucinous neoplasm (IPMN), mucinous cystadenoma, serous cystadenoma, chronic pancreatitis, neuroendocrine tumors, or solid pseudopapillary tumors

Diagnostic Test: 16s rRNA or shotgun metagenomics

Interventions

16s rRNA or shotgun metagenomics DIAGNOSTIC_TEST

16s rRNA or shotgun metagenomics on oral and fecal samples

Benign or low-grade malignant pancreatic tumor; Pancreatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a pancreatic tumor detected via imaging

You may qualify if:

• Patients with a pancreatic tumor detected via imaging with no prior treatment before sample collection
• Patients volunteer to provide oral and fecal samples

You may not qualify if:

• Current or previous diagnoses of (a) other malignancies, (b) infectious diseases, (c) oral or gastrointestinal disorders (d) psychiatric or neurodegenerative disorders
• Specific medical procedures or interventions within defined periods, including (a) antibiotic, hormone therapy, or immunosuppressant within the past three months, (b) gastrointestinal reconstructive surgery within the past three months, (c) frequent use of cathartics, antidiarrheals, or therapeutic doses of probiotics within the past month, (d) oral or gastrointestinal examinations within the past three days

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of General Surgery, Peking Union Medical College Hospital (PUMCH)

Beijing, Beijing Municipality, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

16S rRNA or shot-gun metagenomics of oral and fecal samples from patients with pancreatic neoplasms

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Menghua Dai, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 26, 2024
• Study Start: November 1, 2020
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)