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Microbial ColonizationNCT05412628

Investigating the Association Between Microbiota and Esophageal/Oropharyngeal Cancer

A study testing Oral swab test in people with Microbial Colonization and Esophageal Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 99 yearsHealthy volunteers can take part
What is being tested?
Oral swab test
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteTaiwan
Study dates
15 Mar 2022to 14 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hsueh-Chien Chiang, M.D. contact

2353535

scion456scion@gmail.com

Jenn-Wei Chen, Ph.D contact

2353535

jc923@mail.ncku.edu.tw

Taiwan1 site, 1 recruiting
  • National Cheng-Kung University Hospital

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

    Hsueh-Chien Chiang, 2353535, scion456scion@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: Investigating the Association, Disease Mechanism, and Clinical Application Between Microbiota and Oropharyngeal and Esophageal Cancer

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.

Read more

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.

Read the detailed description

Esophageal cancer is one of the most common gastrointestinal malignant diseases worldwide with an estimated 456,000 incident cases annually. Esophageal cancer has a poor prognosis and high mortality rate. The 5-year survival rate is around 15%-25%. The treatment options of esophageal cancer can be divided into curative treatment and palliative treatment, while endoscopy, surgery and chemoradiotherapy were involved. However, 60-70% patients diagnosed with esophageal cancer are not eligible for curative treatment. In these patients, chemoradiotherapy is the standard for unresectable esophageal cancer, but the treatment outcome remains poor. In the literatures, the complete response rate of chemoradiotherapy in advanced esophageal cancer was about 20%, and the 2-year overall survival rate was 40%. Therefore, early detection and prediction of esophageal cancer are needed. Besides, the inconsistency of treatment effect of chemoradiotherapy may indicate some differences of esophageal cancer microenvironment among the patients. Finding out the affecting factors of microenvironment may help the decision making of treatment options and the prediction of disease prognosis. Furthermore, if we can change the affecting factors in microenvironment, we may be able to prevent the esophageal cancer formation or progression.

Esophageal tumor initiation is associated with environmental exposures, chronic inflammation, and immune cells. Several genetic and environmental factors play key roles in the formation and progression of esophageal cancer. Refluxed gastric and bile acids induce chronic inflammation and the development of intestinal metaplasia (Barrett's esophagus), which is the precursor lesion to esophageal adenocarcinoma. Toxic agent like tobacco and alcohol can cause direct esophageal injury and production of reactive oxygen species (ROS). ROS production causes direct DNA damage and tumor-initiating mutations. Besides, some literatures had reported the possible correlation with microbiota and cancer formation. Commensal bacteria (the microbiota) normally live in the gastrointestinal tract with host cell. Disruption of the relationship (dysbiosis) can influence the metabolism, tissue development, and immune response, which may cause damage to epithelial barriers, inflammation, and inducing DNA and pro-oncogenic signaling, leading to carcinogenesis in the gastrointestinal tract. The role of microbiota in the esophagus has not been widely investigated. Increasing of gram-negative bacteria increases the production of lipopolysaccharide (LPS), leading to inflammation and increased gastric reflux. The gut microbiota is associated with nutrition, the immune system, and defense of the host. It produces short chain fatty acids via anaerobic fermentation of dietary fibers in the intestine. Compared with healthy individuals, the abundance of short chain fatty acids -producing bacteria decreased and the abundance of lipopolysaccharide (LPS) -producing bacteria increased in esophageal cancer patients. Butyrate, one of the short chain fatty acids, decreases LPS-induced cytokine expression and NF-κB activation in lamina propria mononuclear cells. Esophageal microbiota theoretically plays a role in esophageal carcinogenesis.

Esophageal cancer is composed of esophageal adenocarcinoma and esophageal squamous cell carcinoma (ESCC). In esophageal adenocarcinoma, a decrease of Firmicutes, and an increase of Proteobacteria, Lactobacillus fermentum, and Tannerella forsythia have been reported. In esophageal squamous cell carcinoma, a reduction of Streptococcus species and an increase of Fusobacterium nucleatum and Porphyromonas gingivalis were observed. In Taiwan, patients with primary oropharyngeal cancer had ten times the risk of second esophageal cancer compared to the general population, and vice versa. Some specific bacteria may be associated with the co-existence of oropharyngeal cancer and esophageal cancer. However, diet is one of the most potent factors in determining microbiome integrity. Owing to the dietary difference between easterners and westerners, the dominant microbiota affecting esophageal cancer may be different. Finding out the esophageal cancer-associated specific bacteria of microbiota in Taiwan is important for further research and application for our patients.

Previously, some microorganisms could not be cultured, which would make the microbiota detection incomplete. Nowadays, 16S ribosomal RNA (16S rRNA) sequences had replaced the culture methods in detection of microbiota. In our study, we aim to compare the microbiota among healthy individuals, patients with esophageal cancer, oropharyngeal cancer, and concurrent esophageal cancer with oropharyngeal cancer in Taiwan. Through the comparison, we may find the potential risky microbiota for cancer formation or progression in Taiwan.

Being tested
Oral swab test
Medical subject headings
Communicable Diseases, Esophageal Neoplasms, Oropharyngeal Neoplasms, Neoplasms, Multiple Primary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral swab testDiagnostic test

    Also called Esophageal mucosal tissue biopsy

    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.

Study groups in NCT05412628
Study groupRoleWhat they receive
Esophageal cancer groupExperimentalpatients aged ≥ 20 years with esophageal cancer
Receives: Diagnostic Test: Oral swab test
Oropharyngeal cancer groupExperimentalpatients aged ≥ 20 years with oropharyngeal cancer
Receives: Diagnostic Test: Oral swab test
Synchronous cancer groupExperimentalpatients aged ≥ 20 years with synchronous oropharyngeal cancer and esophageal cancer
Receives: Diagnostic Test: Oral swab test
Control groupPlacebo comparatorpatients aged ≥ 20 years with symptoms of dysphagia without cancer
Receives: Diagnostic Test: Oral swab test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 week

Secondary outcomes (1)
  1. To analyze the distribution difference of microbiota among the patients with esophageal cancer/oropharyngeal cancer and non-cancer control

    The study will compare the microbiota by sequencing 16S rRNA (measured as percentage abundance per microbial species and differences in percentage abundance between the control group and cancer group). In order to compare the difference of microbiota among esophageal cancer patients, oropharyngeal cancer patients, synchronous cancer patients, and non-cancer control. 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.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2022
  2. Study start15 Mar 2022
  3. Primary completion14 Feb 2024 (estimated)
  4. Study completion14 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05412628
Sponsor's protocol ID
A-BR-110-487
Status last verified
Apr 2023
First submitted
16 Mar 2022
Last updated
23 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 28648400
  • 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.

    PubMed 26923327
  • 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.

    PubMed 22344232
  • 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.

    PubMed 31466948
  • 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.

    PubMed 29196415
  • 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.

    PubMed 28562351
  • 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.

    PubMed 34733778

Questions about this trial

What is this clinical trial studying?

A study testing Oral swab test in people with Microbial Colonization and Esophageal Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hsueh-Chien Chiang, M.D. (2353535, scion456scion@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To analyze the similarity of microbiota distribution between the buccal field and the esophageal area in the same patient (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05412628, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.

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