Cervical Cancer Susceptible Population ClassificationNCT06405945
Cervical Cancer Susceptible Population Classification
An observational study of Cervical Cancer Susceptible Population Classification, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Cervical cancer is the third most common lethal tumor globally, causing around a quarter million deaths annually, despite the availability of HPV vaccines. Recent Genome-wide association studies (GWAS) have identified numerous genetic markers linked to cervical cancer, including rs10175462, rs10007915, rs35721900, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Susceptible Population Classification
- What is being tested?
- PCR and sequence
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to Jun 2036
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: HPV positive person at average risk of cervical cancer
Who may be able to join
- Subjects aged >=18 years at time of consent
- Intended to undergo screening colposcopy
- Considered by a physician or healthcare provider as being of "average risk" for cervical cancer
- Willing to consent to blood draw cervical disease treatments
- Willing to sonsent to follow-up for five years as per protocol
Who cannot join
- History of cervical cancer
- History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study)
- Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs.
- Any major physical trauma (e.g. disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent
- Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of USTC
Hefei, Anhui, 230001
Yingying Wang, Doctor, 18652270921, yingyingwang@ustc.edu.cn
Tingting Zhao, Master, 17333296213, heyppy@163.com
About this study
Official title: Evalutaion of the SNPs Test in Average Cervical Cancer Screening Episode
Cervical cancer is the third most common lethal tumor globally, causing around a quarter million deaths annually, despite the availability of HPV vaccines. Recent Genome-wide association studies (GWAS) have identified numerous genetic markers linked to cervical cancer, including rs10175462, rs10007915, rs35721900, and rs61646675, which have been verified as being related to susceptibility to cervical cancer. However, many reports lack clarity, consistency, and validation. In this comprehensive study, we will analyze the genomic risk factors associated with cervical cancer, classify individuals into different risk categories, and explore potential biomarkers and therapeutics.
- Being tested
- PCR and sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR and sequenceGenetic
sequence the mutatation SNPs
| Study group | Role | What they receive |
|---|---|---|
| Normal | HPV negative， TCT negative Receives: Genetic: PCR and sequence | |
| LSIL | HPV postive, TCT: CIN I or Colposcopy LSIL Receives: Genetic: PCR and sequence | |
| HSIL | HPV postive, TCT: CIN II-III or Colposcopy HSIL Receives: Genetic: PCR and sequence | |
| cervical cancer | HPV positive, Histopathology: cervical cancer Receives: Genetic: PCR and sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evalutaiton of the SNPs test in an average cervical cancer patients screening episode
Measured: two years
Secondary outcomes (1)
Classified susceptied person into different ladders
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 May 2024
- Primary completion30 Apr 2034 (estimated)
- Study completionJun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer Susceptible Population ClassificationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yingying Wang, Doctor, Study chair, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405945
- Sponsor's protocol ID
- Wila-Cer-01
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evalutaion of the SNPs Test in Average Cervical Cancer Screening Episode
- ClinicalTrials.gov ID
- NCT06405945
- Acronym / sponsor ID
- Wila-Cer-01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2034 (estimated)
- Study completion
- Jun 2036 (estimated)
- First posted
- 9 May 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.
Cervical cancer is the third most common lethal tumor globally, causing around a quarter million deaths annually, despite the availability of HPV vaccines. Recent Genome-wide association studies (GWAS) have identified numerous genetic markers linked to cervical cancer, including rs10175462, rs10007915, rs35721900, and rs61646675, which have been verified as being related to susceptibility to cervical cancer. However, many reports lack clarity, consistency, and validation. In this comprehensive study, we will analyze the genomic risk factors associated with cervical cancer, classify individuals into different risk categories, and explore potential biomarkers and therapeutics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Genetic: PCR and sequenceHPV negative， TCT negative |
| LSIL | – | Genetic: PCR and sequenceHPV postive, TCT: CIN I or Colposcopy LSIL |
| HSIL | – | Genetic: PCR and sequenceHPV postive, TCT: CIN II-III or Colposcopy HSIL |
| cervical cancer | – | Genetic: PCR and sequenceHPV positive, Histopathology: cervical cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HPV positive person at average risk of cervical cancer
Key inclusion criteria (5 listed)
- Subjects aged >=18 years at time of consent
- Intended to undergo screening colposcopy
- Considered by a physician or healthcare provider as being of "average risk" for cervical cancer
- Willing to consent to blood draw cervical disease treatments
- Willing to sonsent to follow-up for five years as per protocol
Key exclusion criteria (5 listed)
- History of cervical cancer
- History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study)
- Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs.
- Any major physical trauma (e.g. disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent
- Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCR and sequencesequence the mutatation SNPs | Genetic | HSIL, LSIL, Normal, cervical cancer |
Primary outcome
Evalutaiton of the SNPs test in an average cervical cancer patients screening episode
Time frame: two years
1 secondary outcome
Classified susceptied person into different ladders
Time frame: two years
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 9 May 2024.
- Individual participant dataSharing planned: Undecided
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.
Yingying Wang, Doctor study chair
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer Susceptible Population Classification, run by Anhui Provincial Hospital at 1 site in China.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yingying Wang, Doctor (18652270921, yingyingwang@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evalutaiton of the SNPs test in an average cervical cancer patients screening episode (time frame: two years). 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 9 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.