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Investigating the Association Between Microbiota and Esophageal/Oropharyngeal Cancer

NCT05412628 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-06-23

No results posted yet for this study

Summary

Background: Esophageal cancer commonly occurs in middle-aged man. It is ranked to the 6th common cancer and 5th cancer-related death in Taiwanese male, and sometimes co-exist with oropharyngeal cancer, which impacts our national economics and productivity a lot. To improve the prognosis of esophageal cancer, we should contribute to early diagnosis and improved treatment of the disease. Recent studies showed oral and esophageal dysbiosis may lead to oropharyngeal and esophageal cancer.

Aim: To investigate whether oral microbiota is similar to esophageal microbiota. To investigate whether oral microbiota can be a non-invasive biomarker of oropharyngeal cancer, esophageal cancer, synchronous cancer and chemoradiation resistance. And whether probiotic supplement can improve oral/esophageal dysbiosis in order to prevent esophageal cancer.

Study design: This study compares the oral/esophageal microbiota composition between oropharyngeal cancer cases, esophageal cancer cases, synchronous cancer cases and non-cancer controls. In addition, the link between oral and esophageal microbiota will be explored. The study will identify the microbiota related with esophageal cancer development. We will also validate the effect of probiotic supplementation on improving oral/esophageal dysbiosis.

Expected result and significance: Examination of oral microbiota has the potential to become a non-invasive tool for oropharyngeal cancer, esophageal cancer, and synchronous cancer. Probiotic supplementation has the potential to improve oral dysbiosis.

Conditions

  • Microbial Colonization
  • Esophageal Cancer
  • Oropharyngeal Neoplasms
  • Synchronous Neoplasm

Interventions

DIAGNOSTIC_TEST

Oral swab test

In this study, we will perform tissue biopsy at esophageal tumor site in esophageal cancer patients and perform random biopsy at middle esophagus in patients without esophageal cancer. Besides, we will take oral swab in all participants.

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • Wei-Lun Chang, M.D. Ph.D · National Cheng-Kung University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2024-02-14
Completion
2024-02-14

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05412628 on ClinicalTrials.gov