The Standard Management of HPV Infection

the High-Risk HPV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03577925
• Other study ID #: ZYLX201705
• Status: Recruiting
• Start date: October 1, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2018
• Source: Capital Medical University
• Contact: YU mei Wu, Doctor
• Phone: 86 13701016571
• Email: wym597118[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 30, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Papillomavirus Infections
• the High-Risk HPV Infection

Intervention

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.

Locations

Country	Name	City	State
China	Yu mei Wu	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The HR-HPV clearance	The difference of the HR-HPV clearance between HSIL and stage IA1 cervical squamous cancer	24 months