Cervical intraepithelial neoplasia 3
Conditions
Interventions
HPV vaccination after coniztion
Sponsors
Kansai Clinical Oncology Group
Sankai Gynecologic Study Group Other Gynecologic Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Cohort for post-conization HPV infection 1)Age below 40 years at the time of conization. 2)Performance status (PS) 0 to 1. 3)Diagnosis of CIN 3 confirmed with conization at least 1 year and less than 3 years before. 4)Written voluntary consent to participate in the study after receiving a full explanation of the study details using a given informed consent document and other written information. Cohort for post-conization HPV vaccination 1)Age below 40 years. 2)PS 0 to 1. 3)Patients who are scheduled for conization for CIN 3 diagnosed with histology and colposcopy and who consent to receive an HPV vaccine (Cervarix) after conization (informed consent should be obtained prior to conization). 4)Patients who have been suspected to have CIN 3 before conization but are found to have minor invasive cancer after conization and receive HPV vaccination with the uterus preserved; these patients are considered eligible for the study. 5)Patients who have been included in the cohort for post-conization HPV vaccination but are found to be pregnant after vaccination and cannot complete 3 HPV vaccinations; these patients are also considered eligible and will be analyzed. 6)Patients who are found to be pregnant after being included in the cohort for post-conization HPV vaccination and completing 3 HPV vaccinations; these patients are also considered eligible for the study. 7)Written voluntary consent to participate in the study after receiving a full explanation of the study details using a given informed consent document and other written information.
Exclusion criteria
Exclusion criteria: 1)Adenocarcinomas 2)Previous HPV vaccination 3)Age of 40 years or over 4)Invasive cancer suggested with cytology, histology, and/or colposcopy before conization. 5)Patients who are found to have invasive cancer or who undergo hysterectomy from their own will after conization should be excluded from the study even after enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Investigation on Post-conization HPV infection rate. 2. Investigation on post-conization HPV re-infection prophylazis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of recurrence of CIN 2. Significant adverse reactions to HPV vaccination | — |
Countries
Japan
Contacts
Public ContactTsutomu Tabata
Mie University School of Medicine Obstetrics and Gynecology
Outcome results
None listed