Cervical Cancer Susceptible Population Classification

NCT ID: NCT06405945

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2036-06-30

Brief Summary

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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

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Conditions

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Cervical Cancer Susceptible Population Classification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal

HPV negative, TCT negative

PCR and sequence

Intervention Type GENETIC

sequence the mutatation SNPs

LSIL

HPV postive, TCT: CIN I or Colposcopy LSIL

PCR and sequence

Intervention Type GENETIC

sequence the mutatation SNPs

HSIL

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

PCR and sequence

Intervention Type GENETIC

sequence the mutatation SNPs

cervical cancer

HPV positive, Histopathology: cervical cancer

PCR and sequence

Intervention Type GENETIC

sequence the mutatation SNPs

Interventions

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PCR and sequence

sequence the mutatation SNPs

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Anhui Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingying Wang, Doctor

Role: STUDY_CHAIR

The First Affiliated Hospital of USTC

Locations

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The First Affiliated Hospital of USTC

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yingying Wang, Doctor

Role: CONTACT

18652270921

Tingting Zhao, Master

Role: CONTACT

17333296213

Facility Contacts

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Yingying Wang, Doctor

Role: primary

18652270921

Tingting Zhao, Master

Role: backup

17333296213

Other Identifiers

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Wila-Cer-01

Identifier Type: -

Identifier Source: org_study_id

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