The Microbiome of Oesophageal Squamous Cell Carcinoma

NCT04425122 | Unknown

• 1 other identifier: CRE-2020.186
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study on the microbiota associated with oesophageal squamous cell carcinoma (SCC). Patients with newly diagnosed SCC of oesophagus would be recruited for taking samples of oral and oesophageal rinse, tissue biopsies for investigation of the microbiota of oesophageal cancer. Control patients would be identified from patients scheduled for routine endoscopy.

Conditions

Esophageal Cancer; Microbial Colonization

Keywords

Esophageal squamous cell carcinoma; Microbiome

Outcome Measures

Primary Outcomes (1)

• Microbiological culture from biopsy specimens

  Pattern of culture from specimens obtained, compared between cancer and non-cancer

  1month

Secondary Outcomes (3)

• Loco-regional recurrence free survival

  5 year

• Disease specific survival

  5 year

• Overall survival

  5 year

Study Arms (2)

Esophageal cancer

Patients with esophageal cancer (SCC)

Diagnostic Test: Upper endoscopy

Non-cancer group

Non-cancer patients scheduled for upper endoscopy

Diagnostic Test: Upper endoscopy

Interventions

Upper endoscopy DIAGNOSTIC_TEST

Upper endoscopy would be performed. Biopsy would be taken from oesophageal cancer tissue and adjacent non-cancerous mucosa

Esophageal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General Inclusion Criteria for both study groups, Test group and Control group. 1. 18 Years and older 2. Able to provide informed consent 3. No cognitive impairment General Exclusion Criteria for both study groups, Test group and Control group. 1\) On anticoagulation including Plavix, warfarin and NOAC's Test group: Additional Specific Inclusion Criteria: 1\) Newly diagnosed OESCC or oesophageal dysplasia. Control group: Additional Specific Inclusion Criteria: 1\) Patients undergoing an OGD without a history of malignancy Withdrawal criteria: 1. The subject withdraws consent. 2. If the subject is non-cooperative and/ or undisciplined.

You may qualify if:

• Years and older
• Able to provide informed consent
• No cognitive impairment
• Newly diagnosed OESCC or oesophageal dysplasia.

You may not qualify if:

• \) On anticoagulation including Plavix, warfarin and NOAC's
• Control group:
• Patients undergoing an OGD without a history of malignancy
• Years and older
• Able to provide informed consent
• No cognitive impairment
• \) On anticoagulation including Plavix, warfarin and NOAC's

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Oral and esophageal rinse 2. Biopsy samples from oesophageal cancer, adjacent non-cancer mucosa, as well as random oesophageal biopsies from healthy individuals

MeSH Terms

Conditions

Esophageal Neoplasms; Communicable Diseases; Esophageal Squamous Cell Carcinoma

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Hon Chi Yip, FRCSEd

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hon Chi Yip, FRCSEd

CONTACT

35052627; hcyip@surgery.cuhk.edu.hk

Philip Wai Yan Chiu, MD

CONTACT

35052627; philipchiu@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: July 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

HK (1)