The Standard Management of HPV Infection

The Standard Mangagement of High-Risk HPV Infection During Follow-up Visits

High-risk human papillomavirus (HR-HPV) infection is a necessary condition in the occurence and development of cervical squamous intraepithelial lesion (SIL) and cervical cancer. There are cases that high-grade SIL (HSIL) and stage IA1 cervical squamous cancer remain or reoccur, or even become more severe after conization. The infection situation of HR-HPV, which plays an important role in the prognosis of cervical lesion, should be consulted in the management and follw-up after conization. It is worthwhile making further study in the specific practical significance of the HR-HPV in the prognosis of cervical lesion, as well as the high-risk factors that influence the prognosis of HR-HPV.

Study Overview

• Status: Unknown
• Conditions: the High-Risk HPV Infection
• Intervention / Treatment: Diagnostic test: HPV genotype test

Detailed Description

Main purpose:To work out the standard management of HPV infection by following up the HPV infection situation of the patients with high-grade SIL (HSIL) and stage IA1 cervical squamous cancer after conization.

Research design:First, to do the retrospective analysis toward the patients who received conization between Jan 2009 to Aug 2016.Second,to do the prospective analysis toward the patients who received conization between Spt 2016 to Aug 2018.

Inclusive criteria of study population:The patients who had finished HPV genotype testing before conization;who had never received treatment other than conization;who were histologically diagnosed as HSIL or IA1 cervical squamous cancer;who had not been diagnosed as any cervical diseases before;who were under age 70;who did not have any severe diseases that influence the follow-up.

Follow-up methods:to do the follow-up to the target patients by 3,6,9,12,18,24 months after conization.

Follow-up contents:the HR-HPV genotype infection before conization;the grade of lesion;the age when received conization;the gravity and parity;the situation of the glands invovement

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Yu mei Wu
      • Contact: Yu mei Wu, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

the HR-HPV genotype tested positive patients with HSIL or stage IA1 cervical squamous cancer who received conization at genocology oncology department in Beijing Obstetrics and Gynecology Hospital during Oct 2016 to Oct 2018.

Description

Inclusion Criteria:

• age not above 70
• histologically diagnosed as HSIL or stage IA1 cervical squamous cancer
• received conization in Beijing Obstetrics and Gynecology Hospital
• HR-HPV infected without any treatment other than conization
• HR-HPV genotype tested before coniztion

Exclusion Criteria:

• age above 70
• with severe desease that influence the follow-up
• received other treatment on cervical lesion
• data incompleted
• not meet the inclusive criteria

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HSIL; the patients with HSIL	Diagnostic test: HPV genotype test; HPV genotype test is a diagnostic test by smearing the cervix to find out whether a patient is hpv infected, and if infected, the test can descover the concrete hpv genotype.
stage IA1 cervical squamous cancer; the patients with stage IA1 cervical squamous cancer	Diagnostic test: HPV genotype test; HPV genotype test is a diagnostic test by smearing the cervix to find out whether a patient is hpv infected, and if infected, the test can descover the concrete hpv genotype.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The HR-HPV clearance	The difference of the HR-HPV clearance between HSIL and stage IA1 cervical squamous cancer	24 months

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Study Director: Yu mei Wu, Doctor, Beijing obstetrics and gynecology hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: June 24, 2018
• First Submitted That Met QC Criteria: June 24, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: June 24, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Infections; Communicable Diseases; Papillomavirus Infections
• Other Study ID Numbers: ZYLX201705

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