UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031433
Receipt No. R000035835
Scientific Title 5-aminolevulinic acidphotodynamic therapy for cervical intraepithelial neoplasia
Date of disclosure of the study information 2019/04/01
Last modified on 2018/02/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 5-aminolevulinic acidphotodynamic therapy for cervical intraepithelial neoplasia
Acronym 5-ALA-PDT for CIN
Scientific Title 5-aminolevulinic acidphotodynamic therapy for cervical intraepithelial neoplasia
Scientific Title:Acronym 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
1st name
Middle name
Last name Masato Kita
Organization Kansai Medical University
Division name Obstetrics and gynecology
Zip code
Address 2-3-1, Shinmachi, Hirakata-shi, Osaka
TEL 072-804-0101
Email kitamas@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoji Hisamatsu
Organization Kansai Medical University
Division name Obstetrics and gynecology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.