Cervical Cancer Susceptible Population Classification

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer Susceptible Population Classification
• Intervention / Treatment: Genetic: PCR and sequence

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Yingying Wang, Doctor; Phone Number: 18652270921; Email: yingyingwang@ustc.edu.cn
• Study Contact Backup: Name: Tingting Zhao, Master; Phone Number: 17333296213; Email: heyppy@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Recruiting
      • The First Affiliated hospital of USTC
      • Contact: Yingying Wang, Doctor; Phone Number: 18652270921; Email: yingyingwang@ustc.edu.cn
      • Contact: Tingting Zhao, Master; Phone Number: 17333296213; Email: heyppy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

HPV positive person at average risk of cervical cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal; HPV negative， TCT negative	Genetic: PCR and sequence; sequence the mutatation SNPs
LSIL; HPV postive, TCT: CIN I or Colposcopy LSIL	Genetic: PCR and sequence; sequence the mutatation SNPs
HSIL; HPV postive, TCT: CIN II-III or Colposcopy HSIL	Genetic: PCR and sequence; sequence the mutatation SNPs
cervical cancer; HPV positive, Histopathology: cervical cancer	Genetic: PCR and sequence; sequence the mutatation SNPs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evalutaiton of the SNPs test in an average cervical cancer patients screening episode	two years

Secondary Outcome Measures

Outcome Measure	Time Frame
Classified susceptied person into different ladders	two years

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Investigators: Study Chair: Yingying Wang, Doctor, The First Affiliated hospital of USTC

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): April 30, 2034
• Study Completion (Estimated): June 1, 2036

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: Wila-Cer-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No