Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias
Кључне речи
Апстрактан
Опис
Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with plantar warts. Investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the purpose of the study is to evaluation local hyperthermia in the treatment of cervical intraepithelial neoplasias grade I and II after 3 months, with positive high-risk type HPVs, and patients with positive testing for high risk HPVs. Appropriate control arms were designed for different conditions. One control arm is local hyperthermia at 37°C for 30 mins targeted for CINⅠ, the other control arm is LEEP targeted for CINⅡ. After 3 months, to evaluate the effectivity of local hyperthermia.
Датуми
| Последња верификација: | 01/31/2020 |
| Фирст Субмиттед: | 07/21/2017 |
| Предвиђена пријава послата: | 02/10/2018 |
| Прво објављено: | 02/18/2018 |
| Послато последње ажурирање: | 05/21/2020 |
| Последње ажурирање објављено: | 05/21/2020 |
| Стварни датум почетка студије: | 01/27/2018 |
| Процењени датум примарног завршетка: | 05/07/2020 |
| Предвиђени датум завршетка студије: | 07/31/2020 |
Стање или болест
Интервенција / лечење
Device: local hyperthermia at 37℃ for 30 mins
Device: coniztion of the cervix treatment
Device: Local Hyperthermia at 44℃
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Experimental: Local Hyperthermia at 44℃ for HPV+/CIN-1 Local hyperthermia at 44℃ for 30 mins on cervical region, at days of 1,2,3 and 17, 18. HPV+ and normal cytology or HPV+/CIN-1 | |
| Sham Comparator: local hyperthermia at 37℃ for 30 mins HPV+/CIN-1 | Device: local hyperthermia at 37℃ for 30 mins As a control, for patients with HPV+/CIN-1 or HPV+ with normal cytology, hyperthermia at 37℃ is applied |
| Active Comparator: coniztion of the cervix treatment coniztion of cervix for HPV+/CIN2, including LEEP or cold knife coniztion | Device: coniztion of the cervix treatment For patients with HPV+ / CIN-2 |
| Experimental: Local Hyperthermia at 44℃ for CIN2/HPV+ Local hyperthermia at 44℃ for 30 mins at days of 1,2,3 and 17, 18. HPV+ and CIN2. |
Критеријуми
| Узраст подобан за студирање | 18 Years До 18 Years |
| Полови подобни за студирање | Female |
| Прихвата здраве волонтере | да |
| Критеријуми | Inclusion Criteria: - 18-65 years old; generally healthy gynecological conditions, normal sexual life; high risk HPV; Cervical biopsy CIN or no cytological changes; signed informed consent Exclusion Criteria: - Pregnant woman;local or systematic treatment within 3 months; Comorbidity of other severe gynecological inflammation, infection, or tumor; Comorbidity of other serious illnesses； no guarantee of timely treatment and follow-up |
Исход
Примарне мере исхода
1. clearance rates of HPV [3 months after the last time of treatment.]
2. scoring atypia by cytology/pathology [3 months after the last time of treatment.]
Секундарне мере исхода
1. viral load measurement [3 months after the last time of treatment.]
