Cervical Cancer Susceptible Population Classification

University of Science and Technology of China (USTC)

Status: Enrolling

Conditions: Cervical Cancer Susceptible Population Classification

Treatments: Genetic: PCR and sequence

Study type: Observational

Funder types: Other

Identifiers

NCT06405945

Wila-Cer-01

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

10,000 participants in 4 patient groups

Normal

Description:

HPV negative， TCT negative

Treatment:

Genetic: PCR and sequence

LSIL

Description:

HPV postive, TCT: CIN I or Colposcopy LSIL

Treatment:

Genetic: PCR and sequence

HSIL

Description:

HPV postive, TCT: CIN II-III or Colposcopy HSIL

Treatment:

Genetic: PCR and sequence

cervical cancer

Description:

HPV positive, Histopathology: cervical cancer

Treatment:

Genetic: PCR and sequence