Aminolaevulinic Acid Photodynamic Therapy of Cervical Persistent HPV Infection and Cervical Neoplasia
- Conditions
- Cervical Persistent High Risk HPV InfectionCervical Intraepithelial Neoplasia
- Interventions
- Drug: Aminolaevulinic acid photodynamic therapy
- Registration Number
- NCT02304770
- Brief Summary
The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of cervical precancerous lesions in women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 73
-
Premenopausal women, 25-50 years of age
-
Meet one of the 3 following conditions:
high-risk HPV-DNA persistently positive for at least 6 months, without CIN or higher grade lesions as verified by cervical biopsy within the last 3 months; CIN1 as verified by cervical biopsy within the last 3 months and high-risk HPV-DNA positive; CIN2/3 as verified by cervical biopsy within the last 3 months, with intense desire to retain the cervical structure or function
-
Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin ) and endocervical curettage negative
-
In good health condition as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation within the last 4 weeks of the onset of the study
-
Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial;no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
-
Written informed consent signed
- Atypical glandular cells of undetermined significance (AGUS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
- Invasive carcinoma possibility or positive endocervical curettage on colposcopy
- Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
- Undiagnosed vaginal bleeding
- With allergic disease at present; known or suspected porphyria; known allergy to ALA or similar compounds
- Evidence or history of clinically significant cardiovascular, endocrine, neurologic, pulmonary, hematological, immunological, psychiatric, metabolic disease or other serious diseases
- Pregnancy or nursing
- Therapeutic drug or other therapeutic measures applied on cervix or rectum within the last 2 weeks of the onset of the study
- Participation in any clinical studies within the last 30 days
- Subjects that the investigators judged to be not suitable to participate the study besides above
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CIN 1 with high risk HPV infection Aminolaevulinic acid photodynamic therapy Aminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 1 and high risk HPV infection CIN 2/3 Aminolaevulinic acid photodynamic therapy Aminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 2/3 cervical persistent high risk HPV infection Aminolaevulinic acid photodynamic therapy Aminolaevulinic acid photodynamic therapy for the treatment of patients with cervical persistent high risk HPV infection
- Primary Outcome Measures
Name Time Method Response Rate 3 months after treatments Based on histology
clearance of high risk HPV 3 months after treatments proportion of patients with high risk HPV clearance
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The First Affliated Hospital with Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The Obstetrics & Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Women's Hospital School of Medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China