Investigating the Association Between Microbiota and Esophageal/Oropharyngeal Cancer

NCT05412628 | Unknown DMC

• 1 other identifier: A-BR-110-487
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• To analyze the similarity of microbiota distribution between the buccal field and the esophageal area in the same patient

  We will send one patient's oral swab and esophageal mucosal tissue for screening microbiota by sequencing 16S rRNA (measured as percentage abundance per microbial species and differences in percentage abundance between the esophagus and mouth). In order to compare the similarity of microbiota between mouth and esophagus. The raw tags of data will be transformed into high-quality clean tags through the QIIME quality control process. Both alpha- and beta-diversity will be calculated with QIIME software and display with R software. We will use the Ace index to assess the richness of OTUs community and the Shannon index to assess the evenness of community diversity. Weighted UniFrac will be implemented to manifest the phylogenetic relationship of beta-diversity. To find out different genera of bacterial composition between groups, the student's t-test will be employed.

  1 week

Secondary Outcomes (1)

• To analyze the distribution difference of microbiota among the patients with esophageal cancer/oropharyngeal cancer and non-cancer control

  1 week

Study Arms (4)

Esophageal cancer group

EXPERIMENTAL

patients aged ≥ 20 years with esophageal cancer

Diagnostic Test: Oral swab test

Oropharyngeal cancer group

EXPERIMENTAL

patients aged ≥ 20 years with oropharyngeal cancer

Diagnostic Test: Oral swab test

Synchronous cancer group

EXPERIMENTAL

patients aged ≥ 20 years with synchronous oropharyngeal cancer and esophageal cancer

Diagnostic Test: Oral swab test

Control group

PLACEBO COMPARATOR

patients aged ≥ 20 years with symptoms of dysphagia without cancer

Diagnostic Test: Oral swab test

Interventions

Oral swab test DIAGNOSTIC_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.

Also known as: Esophageal mucosal tissue biopsy

Control group; Esophageal cancer group; Oropharyngeal cancer group; Synchronous cancer group

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants included patients aged ≥ 20 years with oropharyngeal cancer, esophageal cancer, or dyspeptic patients without cancer.

You may not qualify if:

• Patients with other cancer than esophageal cancer or oropharyngeal cancer.
• Patients with bleeding tendency, such as platelet \< 50k, PTinr \> 2, or using anti-coagulants.
• Patients with use of antibiotics within the past 2 weeks

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, Other (Non U.s.), 704, Taiwan

RECRUITING

Related Publications (7)

• Lagergren J, Smyth E, Cunningham D, Lagergren P. Oesophageal cancer. Lancet. 2017 Nov 25;390(10110):2383-2396. doi: 10.1016/S0140-6736(17)31462-9. Epub 2017 Jun 22.

  PMID: 28648400 RESULT

• Lin EW, Karakasheva TA, Hicks PD, Bass AJ, Rustgi AK. The tumor microenvironment in esophageal cancer. Oncogene. 2016 Oct 13;35(41):5337-5349. doi: 10.1038/onc.2016.34. Epub 2016 Feb 29.

  PMID: 26923327 RESULT

• Yang L, Francois F, Pei Z. Molecular pathways: pathogenesis and clinical implications of microbiome alteration in esophagitis and Barrett esophagus. Clin Cancer Res. 2012 Apr 15;18(8):2138-44. doi: 10.1158/1078-0432.CCR-11-0934. Epub 2012 Feb 16.

  PMID: 22344232 RESULT

• Snider EJ, Compres G, Freedberg DE, Khiabanian H, Nobel YR, Stump S, Uhlemann AC, Lightdale CJ, Abrams JA. Alterations to the Esophageal Microbiome Associated with Progression from Barrett's Esophagus to Esophageal Adenocarcinoma. Cancer Epidemiol Biomarkers Prev. 2019 Oct;28(10):1687-1693. doi: 10.1158/1055-9965.EPI-19-0008. Epub 2019 Aug 29.

  PMID: 31466948 RESULT

• Peters BA, Wu J, Pei Z, Yang L, Purdue MP, Freedman ND, Jacobs EJ, Gapstur SM, Hayes RB, Ahn J. Oral Microbiome Composition Reflects Prospective Risk for Esophageal Cancers. Cancer Res. 2017 Dec 1;77(23):6777-6787. doi: 10.1158/0008-5472.CAN-17-1296.

  PMID: 29196415 RESULT

• Lee KD, Wang TY, Lu CH, Huang CE, Chen MC. The bidirectional association between oral cancer and esophageal cancer: A population-based study in Taiwan over a 28-year period. Oncotarget. 2017 Jul 4;8(27):44567-44578. doi: 10.18632/oncotarget.17818.

  PMID: 28562351 RESULT

• Zhou J, Sun S, Luan S, Xiao X, Yang Y, Mao C, Chen L, Zeng X, Zhang Y, Yuan Y. Gut Microbiota for Esophageal Cancer: Role in Carcinogenesis and Clinical Implications. Front Oncol. 2021 Oct 18;11:717242. doi: 10.3389/fonc.2021.717242. eCollection 2021.

  PMID: 34733778 RESULT

MeSH Terms

Conditions

Communicable Diseases; Esophageal Neoplasms; Oropharyngeal Neoplasms; Neoplasms, Multiple Primary

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Wei-Lun Chang, M.D. Ph.D

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsueh-Chien Chiang, M.D.

CONTACT

2353535; scion456scion@gmail.com

Jenn-Wei Chen, Ph.D

CONTACT

2353535; jc923@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: June 9, 2022
• Study Start: March 15, 2022
• Primary Completion: February 14, 2024
• Study Completion: February 14, 2024
• Last Updated: June 23, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

TW (1)