Correlation Between Selenium Levels in Human Tissues and HPV-related Cervical Lesions and Outcomes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorSecond Affiliated Hospital of Wenzhou Medical University

About this trial

This study investigates the relationship between selenium levels in human tissues and the persistence of HPV (human papillomavirus) infection, particularly focusing on cervical-related lesions. The main objectives are to explore the correlation between selenium levels in different body samples (hair, nails, urine, and blood) and to evaluate selenium's potential protective effects against HPV persistence and its progression to cervical lesions.

Key goals of the study include:

Determining whether non-invasive monitoring (e.g., hair, nails, urine) can accurately reflect blood selenium levels.

Understanding how selenium levels fluctuate in women with persistent HPV infection, and whether selenium supplementation can reduce the risk of HPV-related cervical disease progression.

Exploring selenium's role in enhancing immune function, especially in older adults, to help clear HPV infection.

By recruiting volunteers for selenium level testing and tracking HPV-positive women over time, this research aims to provide evidence on the effectiveness of selenium in preventing cervical cancer progression and potentially clearing HPV infections.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 to 65 years;

No history of sexual activity within the past 3 days;

No history of cervical surgery;

No history of using contraceptives, hormone therapy, or exposure to metals;

Disqualifiers

Previous diagnosis of HPV positivity and those who have received treatment;

Pregnant individuals;

Individuals who refuse to cooperate.

Trial population

Part 1 of the Study: Study Subjects: Volunteers (individuals undergoing routine health examinations or university students) Part 2 of the Study: Study Subjects: Hospitalized patients (e.g., vaginal uterine prolapse, uterine fibroids, cervical cancer, endometrial cancer, ovarian cancer, etc.) Part 3 of the Study: Study Subjects: First-time HPV infection patients from the gynecology outpatient clinic of our hospital.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 4 trial groups
Group A: Trial volunteers
Group B: Cervical lesions
Group C: persistent HPV infection
Group D: Non-persistent HPV infection

Trial outcomes

Primary outcomes

1

Selenium Level Assessment:

Measurement of serum selenium content: Determined by atomic fluorescence spectrometry / inductively coupled plasma mass spectrometry.

Time frame
At enrollment, 6 months after enrollment, and 12 months after enrollment

Secondary outcomes

1

Immune Function Evaluation

Complete blood count: White blood cell count, neutrophils, lymphocytes, monocytes, red blood cells, hemoglobin, platelets, CRP. Analysis of immune cells in peripheral blood (flow cytometry): B cells; T cells; NK cells; monocytes.

Time frame
At enrollment, 6 months after enrollment, and 12 months after enrollment
2

HPV and TCT Detection, and Definition of HPV Clearance

HPV detection: Real-time quantitative PCR; TCT detection: Cervical cells are assessed using a liquid-based thin-layer cytology system and classified cytologically. Definition of HPV clearance: * Ineffective: HPV subtype remains positive or increases other subtypes; ② Improvement: ≥1 HPV positive subtype becomes negative while still having HPV infection; ③ Complete clearance: All HPV subtypes become negative.

Time frame
At enrollment, 6 months after enrollment, and 12 months after enrollment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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