Clinical trial NCT06168513: Developing a Real-Time PCR Assay for Fusobacterium and Epidemiological Analysis of Tumor Patients
Official title: Developing a Real-Time PCR Assay for Fusobacterium and Epidemiological Analysis of Tumor Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fusobacterium Infections
Keywords: Fusobacterium
PCR
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2023-12-13
Enrollment: 490
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

Brief summary: 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.

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.

Eligibility criteria: 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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Primary outcomes:
measure: Fusobacterium
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Houwei Zhou, professor
role: STUDY_CHAIR
References: