Brief Title
Aminolaevulinic Acid Photodynamic Therapy of Cervical Persistent HPV Infection and Cervical Neoplasia
Official Title
A Pilot Study of Aminolaevulinic Acid (ALA) Photodynamic Therapy (PDT) in Patients With Cervical Persistent High Risk HPV Infection or Cervical Intraepithelial Neoplasia
Brief Summary
The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of
cervical precancerous lesions in women.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response Rate
Condition
Cervical Persistent High Risk HPV Infection
Intervention
Aminolaevulinic acid photodynamic therapy
Study Arms / Comparison Groups
cervical persistent high risk HPV infection
Description: Aminolaevulinic acid photodynamic therapy for the treatment of patients with cervical persistent high risk HPV infection
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
73
Start Date
January 2015
Completion Date
January 2017
Primary Completion Date
January 2017
Eligibility Criteria
Inclusion Criteria:
1. Premenopausal women, 25-50 years of age
2. 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
3. Satisfactory colposcopy examination (visibility of entire transformation zone and
entire lesion margin ) and endocervical curettage negative
4. 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
5. 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
6. Written informed consent signed
Exclusion Criteria:
1. 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
2. Invasive carcinoma possibility or positive endocervical curettage on colposcopy
3. Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological
infection as per clinical examination
4. Undiagnosed vaginal bleeding
5. With allergic disease at present; known or suspected porphyria; known allergy to ALA
or similar compounds
6. Evidence or history of clinically significant cardiovascular, endocrine, neurologic,
pulmonary, hematological, immunological, psychiatric, metabolic disease or other
serious diseases
7. Pregnancy or nursing
8. Therapeutic drug or other therapeutic measures applied on cervix or rectum within the
last 2 weeks of the onset of the study
9. Participation in any clinical studies within the last 30 days
10. Subjects that the investigators judged to be not suitable to participate the study
besides above
Gender
Female
Ages
25 Years - 50 Years
Accepts Healthy Volunteers
No
Contacts
Beihua Kong, MD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02304770
Organization ID
FDZJALA-201409
Responsible Party
Sponsor
Study Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study Sponsor
Beihua Kong, MD, Principal Investigator, Qilu Hospital of Shandong University
Verification Date
June 2019