The Predictive Role of HPV Integration in HSIL and Cervical Cancer

NCT05300243 | Unknown

• 1 other identifier: 2021-S140
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening.

Conditions

HPV Integration

Outcome Measures

Primary Outcomes (1)

• Tissue pathological diagnosis

  Tissue pathological diagnosis in 1 year since HPV integrated test

  1year since HPV integrated test

Interventions

HPV integration test DIAGNOSTIC_TEST

The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

It is expected to be included in 2000 female in this study.

You may qualify if:

• HPV-positive patients； Patients have completed HPV detection, TCT, and HPV integration detection before surgery or biopsy； Patients with priced diagnoses accepted treatment according to ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors； Patients who are voluntary participants in this research and cooperate to follow-up with subscribing informed consent.

You may not qualify if:

• Patients who are not suitable for the trial； Patients existing other subtype malignancy tumors are still in treatment.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 350000, China

RECRUITING

Study Officials

• Shuang Li

  Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuang Li, PHD

CONTACT

+86 18971625668; shuangli@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 29, 2022
• Study Start: July 7, 2020
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 29, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)