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

January 9, 2023 updated by: Dai Menghua, Peking Union Medical College Hospital

SCREENING ORAL AND GUT MICROBES AS A MORE ACCURATE NON-INVASIVE TOOL FOR PANCREATIC CANCER EARLY DETECTION: A POPULATION-BASED CASE-CONTROL STUDY IN CHINA

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • PUMCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NC
normal control
Other: Oral and Fecal Sample Collection
No interventions
PCA
pancreatic cancer patients
Other: Oral and Fecal Sample Collection
No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
microbial features by 16s rRNA sequencing
Time Frame: within 180 days
within 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Menghua Dai, MD, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-PCAMicrobe-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Oral and Fecal Sample Collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe