The Standard Management of HPV Infection

Capital Medical University

Status: Unknown

Conditions: the High-Risk HPV Infection

Treatments: Diagnostic Test: HPV genotype test

Study type: Observational

Funder types: Other

Identifiers

NCT03577925

ZYLX201705

Details and patient eligibility

About

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.

Full 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

Enrollment: 800 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

800 participants in 2 patient groups

HSIL

Description:

the patients with HSIL

Treatment:

Diagnostic Test: HPV genotype test

stage IA1 cervical squamous cancer

Description:

the patients with stage IA1 cervical squamous cancer

Treatment:

Diagnostic Test: HPV genotype test