Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05412628
Study type Interventional
Source National Cheng-Kung University Hospital
Contact Hsueh-Chien Chiang, M.D.
Phone 2353535
Email scion456scion@gmail.com
Status Recruiting
Phase N/A
Start date March 15, 2022
Completion date February 14, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
Not yet recruiting NCT05542680 - Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer N/A
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Completed NCT00003864 - Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus Phase 2
Recruiting NCT05491616 - Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Completed NCT00199849 - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Phase 1
Completed NCT03756597 - PAN-study: Pan-Cancer Early Detection Study (PAN)
Completed NCT00400114 - Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT04615806 - The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy N/A
Active, not recruiting NCT04566367 - Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer N/A
Active, not recruiting NCT03962179 - Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent) N/A
Terminated NCT01446874 - Prevention of Post-operative Pneumonia (POPP) Phase 2/Phase 3
Completed NCT03468634 - Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy N/A
Active, not recruiting NCT02869217 - Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors Phase 1
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Recruiting NCT01404156 - Preoperative Chemotherapy vs. Chemoradiation in Esophageal / GEJ Adenocarcinoma Phase 2/Phase 3