UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031433 |
|---|---|
| Receipt number | 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 23:13:26 |
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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
| Obstetrics 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
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
hisamayj@kouri.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035835
