Using Digestive Microbial Information to Enhance the Early Detection of Pancreatic Cancer

NCT05689138 | Unknown

• 1 other identifier: PUMCH-PCAMicrobe-1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic cancer (PCA) is a leading death-related cancer. There is an urgent need for accurate, noninvasive diagnostic options in the early detection of pancreatic cancer (PCA), since delayed diagnosis increases the risk of metastasis and recurrence. In this study, by analyzing gut and fecal microbial data among the pancreatic versus healthy populations, we aim to establish an early detection tool to improve PCA detection, and to explore potential diagnostic biomarkers.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• microbial features by 16s rRNA sequencing

  within 180 days

Study Arms (2)

PCA

pancreatic cancer patients

Other: Oral and Fecal Sample Collection

NC

normal control

Other: Oral and Fecal Sample Collection

Interventions

Oral and Fecal Sample Collection OTHER

No interventions

NC; PCA

Eligibility Criteria

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

Study Population

Present/ past diagnosis of (a) other malignancy, (b) infectious diseases, (c) oral or digestive diseases, (d) mental psychiatric or neurodegenerative diseases, (e) chronic diseases that may affect the organ function; Have received certain medical examinations or interventions within specific periods, including (a) antibiotics, hormonotherapy, or immunosuppressor in the past three months, (b) digestive tract reconstructive operation in the past three months, (c) Frequent use of a cathartic, antidiarrheal, or therapeutic dose of probiotics throughout the past one month, (d) Change of diet throughout the past one month, (e) local antibiotics usage in 1 week(skin, antibacterial mouth wash) (f) oral or digestive examination in 3 days.

You may qualify if:

• PCA Newly diagnosed pancreatic cancer patients; No symptoms of jaundice; Did not yet receive any treatment
• NC Individuals who were undergoing routine screenings or physical examination

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

PUMCH

Beijing, Beijing Municipality, 100730, China

Location

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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: September 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

CN (1)