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Recruitment status
Unique ID issued by UMIN UMIN000022113
Receipt No. R000025491
Scientific Title Phase I/IIa clinical trial of PDT for cervical intra-epithelial neoplasia using talaporfin sodium and PD laser.
Date of disclosure of the study information 2016/04/28
Last modified on 2016/04/28

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Basic information
Public title Phase I/IIa clinical trial of PDT for cervical intra-epithelial neoplasia using talaporfin sodium and PD laser.
Acronym Phase I/IIa clinical trial of PDT for cervical intra-epithelial neoplasia using talaporfin sodium and PD laser.
Scientific Title Phase I/IIa clinical trial of PDT for cervical intra-epithelial neoplasia using talaporfin sodium and PD laser.
Scientific Title:Acronym Phase I/IIa clinical trial of PDT for cervical intra-epithelial neoplasia using talaporfin sodium and PD laser.
Region
Japan

Condition
Condition cervical intra-epithelial neoplasia
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish PDT for CIN using talaporfin sodium and PD laser, phase I/IIa clinical trial is planned and performed. Safety and efficacy of PDT for CIN are evaluated in this study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Dose Limiting Toxicity for Laser irradiation
Key secondary outcomes 1.Response Rate 12 weeks after PDT
2.Adverse Event after PDT

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Laser irradiation 4-6 hours after intravenous administration of talaporfin sodium.
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
70 years-old >
Gender Female
Key inclusion criteria 1. Age > 20
2. CIN2 or CIN3 confirmed by histology
3. PS:0 or 1
4. WBC >4,000/mm3
Hb > 10.0g/dL
PLT > 100,000/mm3
AST, ALT < 72U/L
T.Bil > 2.0mg/dL
BUN < 22mg/dL
Serum Creatinin < 1.1mg/dL
5. Case not hoping conization for CIN
6. Case who can admit two weeks in the hospital
7. Case with informed consent
Key exclusion criteria 1. Case with glandular dysplasia, AIS or SCC
2. UCF(Unsatisfactory Colposcopic Findings)
3. Case with double cancer
4. UNcontrollable heart, respiratory, liver or kidney disease
5. Case with the past history of conization or PDT for CIN
6. Case with photosensitivity in the past or taking drugs associated with photosensitivity
7. Case with porfirin disease
8. Case with pregnancy or lactation
9. Case under the other clinical trials
10. Case with inadeqate condition for trial
Target sample size 29

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Sakamoto
Organization Sasaki Foundation Kyoundo Hospital
Division name Dept. of Gynecology
Zip code
Address 1-8, Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan,
TEL 03-3292-2051
Email sakamoto@po.kyoundo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Sakamoto
Organization Sasaki Foundation Kyoundo Hospital
Division name Dept. of Gynecology
Zip code
Address 1-8, Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL 03-3292-2051
Homepage URL
Email sakamoto@po.kyoundo.jp

Sponsor
Institute Sasaki Foundation Kyoundo Hospital
Institute
Department

Funding Source
Organization Sasaki Foundation Kyoundo Hospital
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 28 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
Date of protocol fixation
2016 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 28 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
2016 Year 04 Month 28 Day
Last modified on
2016 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025491

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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