Cervical Intraepithelial Neoplasia (CIN)SeHPVNCT06665841
Correlation Between Selenium Levels in Human Tissues and HPV-related Cervical Lesions and Outcomes
An observational study of Cervical Intraepithelial Neoplasia (CIN) and Cervical Cancer, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia (CIN), Cervical Cancer, Persistent HPV Infection
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Previous diagnosis of HPV positivity and those who have received treatment;
- Pregnant individuals;
- Individuals who refuse to cooperate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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.
Read the detailed description
This prospective study aims to explore the impact of selenium levels in human tissues on the progression of HPV-related cervical lesions and to identify the most appropriate biological samples for monitoring selenium levels. The research is divided into three parts:
Part 1: Volunteer Recruitment and Selenium Level Assessment Healthy volunteers, such as those undergoing regular medical check-ups or university students, will be recruited. Selenium levels in various biological samples-blood, hair (scalp or pubic), urine, and nails-will be measured. The primary goal is to assess the correlation between selenium levels in these different tissues to determine whether non-invasive samples (hair, nails, urine) could be used as reliable indicators of blood selenium levels.
Part 2: Patient Group Sample Collection Samples will be collected from hospitalized patients diagnosed with conditions such as uterine fibroids, cervical cancer, endometrial cancer, and ovarian cancer. These samples will include blood, hair (scalp or pubic), urine, and nails, with the same goal of determining the correlation between selenium levels in various tissues. This part of the study will help assess selenium levels in patients with reproductive system diseases and evaluate any differences compared to healthy individuals.
Part 3: HPV Persistent Infection Group Women with persistent HPV infection (defined as infection with the same HPV type for more than 12 months) will be selected from the gynecology clinic, along with a control group of women with non-persistent HPV infection. Selenium levels and immune function will be evaluated at baseline and again after 12 months. Comparisons will be made between the two groups to assess changes in selenium levels and immune function. Additionally, patients with HPV-related cervical lesions (e.g., CIN or cervical cancer) and those with normal cervical tissues will have their serum selenium levels and immune function assessed.
This part of the study will also include the collection of blood, hair (scalp or pubic), urine, and nail samples from HPV-persistent patients. These patients will be divided into three groups: (1) no treatment, (2) interferon treatment (standard clinical practice), and (3) interferon combined with selenium supplementation. The patients will be monitored for 6 and 12 months to observe changes in HPV status (whether the infection clears or persists) and to analyze selenium levels, immune function, and disease progression in CIN I patients.
Selenium supplementation, provided in the form of nano-selenium capsules, will be administered based on the selenium status determined from the external lab results. Patients will be divided into three groups based on their selenium levels:
Normal selenium levels: 50 µg selenium supplement, taken twice daily. Selenium deficiency: 100 µg selenium supplement, taken twice daily. Severe selenium deficiency: 150 µg selenium supplement, taken twice daily. The study will employ various statistical methods, including correlation analysis, univariate and multivariate analysis, and variance analysis, to evaluate the results. The findings will help determine whether selenium supplementation can aid in HPV clearance, slow the progression of cervical lesions, and enhance immune function, particularly in selenium-deficient individuals.
- Keywords
- Selenium, Persistent HPV Infection, Cervical Lesions
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selenium Level Assessment:
Measurement of serum selenium content: Determined by atomic fluorescence spectrometry / inductively coupled plasma mass spectrometry.
Measured: At enrollment, 6 months after enrollment, and 12 months after enrollment
Secondary outcomes (2)
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.
Measured: At enrollment, 6 months after enrollment, and 12 months after enrollment
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.
Measured: At enrollment, 6 months after enrollment, and 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia (CIN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665841
- Sponsor's protocol ID
- SAHoWMU-CR2024-07-220
- Acronym
- SeHPV
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will be used for publication in academic journals, and therefore individual participant data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Selenium Levels in Human Tissues and HPV-related Cervical Lesions and Outcomes
- ClinicalTrials.gov ID
- NCT06665841
- Acronym / sponsor ID
- SeHPV / SAHoWMU-CR2024-07-220
- Keywords
- Selenium, Persistent HPV Infection, Cervical Lesions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective study aims to explore the impact of selenium levels in human tissues on the progression of HPV-related cervical lesions and to identify the most appropriate biological samples for monitoring selenium levels. The research is divided into three parts:
Part 1: Volunteer Recruitment and Selenium Level Assessment Healthy volunteers, such as those undergoing regular medical check-ups or university students, will be recruited. Selenium levels in various biological samples-blood, hair (scalp or pubic), urine, and nails-will be measured. The primary goal is to assess the correlation between selenium levels in these different tissues to determine whether non-invasive samples (hair, nails, urine) could be used as reliable indicators of blood selenium levels.
Part 2: Patient Group Sample Collection Samples will be collected from hospitalized patients diagnosed with conditions such as uterine fibroids, cervical cancer, endometrial cancer, and ovarian cancer. These samples will include blood, hair (scalp or pubic), urine, and nails, with the same goal of determining the correlation between selenium levels in various tissues. This part of the study will help assess selenium levels in patients with reproductive system diseases and evaluate any differences compared to healthy individuals.
Part 3: HPV Persistent Infection Group Women with persistent HPV infection (defined as infection with the same HPV type for more than 12 months) will be selected from the gynecology clinic, along with a control group of women with non-persistent HPV infection. Selenium levels and immune function will be evaluated at baseline and again after 12 months. Comparisons will be made between the two groups to assess changes in selenium levels and immune function. Additionally, patients with HPV-related cervical lesions (e.g., CIN or cervical cancer) and those with normal cervical tissues will have their serum selenium levels and immune function assessed.
This part of the study will also include the collection of blood, hair (scalp or pubic), urine, and nail samples from HPV-persistent patients. These patients will be divided into three groups: (1) no treatment, (2) interferon treatment (standard clinical practice), and (3) interferon combined with selenium supplementation. The patients will be monitored for 6 and 12 months to observe changes in HPV status (whether the infection clears or persists) and to analyze selenium levels, immune function, and disease progression in CIN I patients.
Selenium supplementation, provided in the form of nano-selenium capsules, will be administered based on the selenium status determined from the external lab results. Patients will be divided into three groups based on their selenium levels:
Normal selenium levels: 50 µg selenium supplement, taken twice daily. Selenium deficiency: 100 µg selenium supplement, taken twice daily. Severe selenium deficiency: 150 µg selenium supplement, taken twice daily. The study will employ various statistical methods, including correlation analysis, univariate and multivariate analysis, and variance analysis, to evaluate the results. The findings will help determine whether selenium supplementation can aid in HPV clearance, slow the progression of cervical lesions, and enhance immune function, particularly in selenium-deficient individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- Previous diagnosis of HPV positivity and those who have received treatment;
- Pregnant individuals;
- Individuals who refuse to cooperate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Selenium Level Assessment:
Time frame: At enrollment, 6 months after enrollment, and 12 months after enrollment
Measurement of serum selenium content: Determined by atomic fluorescence spectrometry / inductively coupled plasma mass spectrometry.
2 secondary outcomes
Immune Function Evaluation
Time frame: At enrollment, 6 months after enrollment, and 12 months after enrollment
HPV and TCT Detection, and Definition of HPV Clearance
Time frame: At enrollment, 6 months after enrollment, and 12 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No. The study will be used for publication in academic journals, and therefore individual participant data (IPD) will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia (CIN) and Cervical Cancer, run by Second Affiliated Hospital of Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xueqiong Zhu (+8613606640759, zjwzzxq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selenium Level Assessment: (time frame: At enrollment, 6 months after enrollment, and 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.