Cervical Cancer Susceptible Population Classification

Recruiting

• Conditions: Cervical Cancer Susceptible Population Classification
• Interventions: Genetic: PCR and sequence

• Registration Number: NCT06405945
• Lead Sponsor: Anhui Provincial Hospital

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-01
• Study First Submitted: 2024-05-05
• Study First Submitted QC: 2024-05-05
• Last Update Submitted: 2024-05-05
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09
• Primary Completion: 2034-04-30
• Study Completion: 2036-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10000

Inclusion Criteria

1. Subjects aged >=18 years at time of consent
2. Intended to undergo screening colposcopy
3. Considered by a physician or healthcare provider as being of "average risk" for cervical cancer
4. Willing to consent to blood draw cervical disease treatments
5. Willing to sonsent to follow-up for five years as per protocol

Exclusion Criteria

1. History of cervical cancer
2. 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)
3. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs.
4. 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
5. Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LSIL	PCR and sequence	HPV postive, TCT: CIN I or Colposcopy LSIL
HSIL	PCR and sequence	HPV postive, TCT: CIN II-III or Colposcopy HSIL
Normal	PCR and sequence	HPV negative， TCT negative
cervical cancer	PCR and sequence	HPV positive, Histopathology: cervical cancer

Primary Outcome Measures

Name	Time	Method
Evalutaiton of the SNPs test in an average cervical cancer patients screening episode	two years

Secondary Outcome Measures

Name	Time	Method
Classified susceptied person into different ladders	two years

Trial Locations

Locations (1)

The First Affiliated Hospital of USTC; 🇨🇳 Hefei, Anhui, China