Status:
COMPLETED
Aminolaevulinic Acid Photodynamic Therapy of Cervical Persistent HPV Infection and Cervical Neoplasia
Lead Sponsor:
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Conditions:
Cervical Persistent High Risk HPV Infection
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
25-50 years
Phase:
PHASE2
Brief Summary
The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of cervical precancerous lesions in women.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT02304770
Start Date
January 1 2015
End Date
January 1 2017
Last Update
June 12 2019
Active Locations (4)
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1
The First Affliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210036
2
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
3
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200011
4
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310006