Developing a Real-Time PCR Assay for Fusobacterium and Epidemiological Analysis of Tumor Patients

This study presents an academic approach to developing a fluorescence quantitative PCR detection method capable of accurately measuring the presence of Fusobacterium (specifically F. nucleatum, F. mortiferium, F. varium, F. ulcerans, F. and F. necrogens) in human fecal samples. It aims to perform an epidemiological analysis on the presence of Fusobacterium in patients with tumors, elucidating the prevalence of Fusobacterium members in this patient population. Additionally, it seeks to investigate the potential correlation between Fusobacterium presence and various test indicators, diagnostic predictions, and prognosis outcomes.

Study Overview

• Status: Recruiting
• Conditions: Fusobacterium Infections

Detailed Description

Fusobacterium nucleatum, a gram-negative obligate anaerobic bacterium, is known to colonize the oral cavity and is implicated in various diseases affecting the oropharynx, gastrointestinal tract, cardiovascular vessels, and genital tract. Precise classification of the Fusobacterium genus is of utmost importance as it will facilitate a deeper understanding of the pathogenicity of its members in tumor development, establish an accurate etiological association with tumors, and ultimately enhance clinical practice and epidemiological investigations.

• Study Type: Observational
• Enrollment (Estimated): 490

Contacts and Locations

• Study Contact: Name: Tingting Shen; Phone Number: +86 15521240170; Email: 517184185@qq.com
• Study Contact Backup: Name: Houwei Zhou, professor; Phone Number: +86 18688489622; Email: hzhou@smu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhujiang Hospital of Southern Medical University
      • Contact: Hongwei Zhou, Professor; Phone Number: +86 18688489622; Email: hzhou@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The inclusion criteria for this study encompassed fecal specimens obtained from patients with a documented history of tumor, specifically those who received their primary or initial tumor diagnosis at our hospital.

Description

Inclusion Criteria:

• The inclusion criteria for this study encompassed fecal specimens obtained from patients with a documented history of tumor, specifically those who received their primary or initial tumor diagnosis at our hospital.
• Inclusion criteria for the control group consisted of the following: (1) Individuals who were in good health, devoid of evident diseases, and possessed normal physical examination reports; (2) Individuals who had not experienced significant chronic illnesses, such as hypertension, diabetes, chronic kidney disease, etc., in recent years, in order to exclude those who had been unwell but had normal physical examination reports; (3) Age and gender were matched with the case group.

Exclusion Criteria:

The exclusion criteria for this study include: A) Individuals who have taken an antimicrobial preparation within the past three months. B) Samples that lack complete information and cannot be traced back to their source. C) Samples with an insufficient volume for detection. D) Samples that do not meet the requirements for sample collection and preservation.

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Case group; The inclusion criteria for this study encompassed fecal specimens obtained from patients with a documented history of tumor, specifically those who received their primary or initial tumor diagnosis at our hospital.
Healthy control; (1) Individuals who were in good health, devoid of evident diseases, and possessed normal physical examination reports; (2) Individuals who had not experienced significant chronic illnesses, such as hypertension, diabetes, chronic kidney disease, etc., in recent years, in order to exclude those who had been unwell but had normal physical examination reports; (3) Age and gender were matched with the case group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusobacterium	Fusobacterium in stool detected using PCR	baseline

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Collaborators: National Natural Science Foundation of China
• Investigators: Study Chair: Houwei Zhou, professor, Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: PCR; Fusobacterium
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Fusobacteriaceae Infections; Fusobacterium Infections
• Other Study ID Numbers: ZhujiangHstt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No