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

NCT06665841 | Not Yet Recruiting

• 1 other identifier: SAHoWMU-CR2024-07-220
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cervical Intraepithelial Neoplasia (CIN); Cervical Cancer; Persistent HPV Infection

Keywords

Selenium; Persistent HPV Infection; Cervical Lesions

Outcome Measures

Primary Outcomes (1)

• Selenium Level Assessment:

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

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

Secondary Outcomes (2)

• Immune Function Evaluation

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

• HPV and TCT Detection, and Definition of HPV Clearance

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

Study Arms (4)

Trial volunteers

Trial volunteers refer to healthy individuals undergoing physical examinations at our hospital or recruited healthy university students.

Cervical lesions

Patients with cervical lesions, including those with uterine fibroids, cervical cancer, endometrial cancer, and ovarian cancer.

persistent HPV infection

Persistent HPV infection refers to the infection by the same type of HPV for more than 12 months.

Non-persistent HPV infection

Non-persistent HPV infection refers to the absence of HPV infection.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: This study is open to individuals who self-identify as female or any gender identity that aligns with the biological sex of female, including transgender women and non-binary individuals who consider themselves female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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;
• No history of cardiovascular, cerebrovascular, liver, kidney, or thyroid diseases;
• All participants must sign a written informed consent form prior to sampling and agree to cooperate with the study.

You may not qualify if:

• Previous diagnosis of HPV positivity and those who have received treatment;
• Pregnant individuals;
• Individuals who refuse to cooperate.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Central Study Contacts

Xueqiong Zhu

CONTACT

+8613606640759; zjwzzxq@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share