UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021386 |
|---|---|
| Receipt number | R000024662 |
| Scientific Title | Photodynamic therapy against cervical intraepithelial neoplasia by talaporfin sodium |
| Date of disclosure of the study information | 2016/03/08 |
| Last modified on | 2016/03/08 21:14:28 |
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Basic information
Public title
Photodynamic therapy against cervical intraepithelial neoplasia by talaporfin sodium
Acronym
Photodynamic therapy against cervical intraepithelial neoplasia by talaporfin sodium
Scientific Title
Photodynamic therapy against cervical intraepithelial neoplasia by talaporfin sodium
Scientific Title:Acronym
Photodynamic therapy against cervical intraepithelial neoplasia by talaporfin sodium
Region
| Japan |
Condition
Condition
cervical intraepithelial neoplasia (CIN1 - CIN3)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The effect of photodynamic therapy by talaporfin sodium against CIN is confirmed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The curative ratio of photodynamic therapy by talaporfin sodium against CIN is confirmed at 2 months and 5 months after PDT.
Key secondary outcomes
The side effects of photodynamic therapy by talaporfin are confirmed.
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
Intravenous administration of talaporfin sodium 40mg/m2. After 4 hours administration, we perform irradiation by PD laser.
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who have CIN1 - CIN3
Key exclusion criteria
The case which has no reported complications
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Murakami Hirotake |
Organization
Hamamatsu University School of Medicine
Division name
Obstetorics and Gynecology
Zip code
Address
1-20-1, Handayama, Higashi-ku Hamamatsu-shi, Shizuoka, 431-3125, Japan
TEL
053-435-2309
obstslot@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Murakami Hirotake |
Organization
Hamamatsu University School of Medicine
Division name
Obstetorics and Gynecology
Zip code
Address
1-20-1, Handayama, Higashi-ku Hamamatsu-shi, Shizuoka, 431-3125, Japan
TEL
053-435-2309
Homepage URL
obstslot@hama-med.ac.jp
Sponsor or person
Institute
Murakami Hirotake
Institute
Department
Personal name
Funding Source
Organization
The research fund of Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
浜松医科大学（静岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 08 | 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
| 2015 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 07 | Day |
Last modified on
| 2016 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024662
