UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	5-aminolevulinic acidphotodynamic therapy for cervical intraepithelial neoplasia
Title of the study (Brief title)	5-ALA-PDT for CIN
Region	Japan

Condition
Condition	cervical intraepithelial neoplasia(CIN)
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to investigate safety and efficacy of 5-ALA-PDT in patients with cervical intraepithelial neoplasia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety(topical pain,erosion and overall status):at each PDT and 12 and 24weeks after last PDT
Key secondary outcomes	Complete Response(CR) rate: 12 and 24weeks after last PDT Treatment time

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Local administration of aminolevulinic acid jelly 2-3hours before PDT PDT: irradiation for a red light of 635nm for 3-6minutes (total 100J/m2)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	50 years-old >
Gender	Female
Key inclusion criteria	1)pathological diagnosis within 3months of the registration of this clinical trial 2)20-50 years-old and premenopausal female 3)ECOG Performance Status(PS) 0-2 4)Patients with organ function is maintained sufficiently 5)Patients with written consent of this clinical trial 6)outpatients
Key exclusion criteria	1)patients with porphyrin hypersensitivity 2)patients with Porphyrias 3)severe drug allergy 4)patients who use a drug causing photosensitivity 5)the patients with other malignant tumors 6)patient with uncontrolled infection 7)patients with myocardial infarction within 6months 8)patients with severe underlying disease 9)patients with severe mental disorders 10)gravida and lactational woman 11)patients judged by investigators as inappropriate to this study
Target sample size	10

Research contact person
Name of lead principal investigator	Masato Kita
Organization	Kansai Medical University
Division name	Obstetrics and gynecology
Address	2-3-1, Shinmachi, Hirakata-shi, Osaka
TEL	072-804-0101
Email	kitamas@hirakata.kmu.ac.jp

Public contact
Name of contact person	Yoji Hisamatsu
Organization	Kansai Medical University
Division name	Obstetrics and gynecology
Address	2-3-1, Shinmachi, Hirakata-shi, Osaka
TEL	072-804-0101
Homepage URL
Email	hisamayj@kouri.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	SBI pharmaceutical Co.,Ltd. Tsukada Medical Reseach Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	関西医科大学付属病院/Kansai Medical University Hospital

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 22 Day
Last modified on	2018 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035835