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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06168513
Enrollment
490
Registered
2023-12-13
Start date
2023-03-01
Completion date
2024-12-31
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fusobacterium Infections

Keywords

Fusobacterium, PCR

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.

Interventions

None listed

Sponsors

National Natural Science Foundation of China
CollaboratorOTHER_GOV
Zhujiang Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL

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

Design outcomes

Primary

MeasureTime frameDescription
FusobacteriumbaselineFusobacterium in stool detected using PCR

Countries

China

Contacts

Primary ContactTingting Shen
517184185@qq.com15521240170
Backup ContactHouwei Zhou, professor
hzhou@smu.edu.cn18688489622

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026