UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010412 |
|---|---|
| Receipt number | R000012090 |
| Scientific Title | Efficacy of photodynamic therapy (PDT) of 5-Aminolevulinic Acid for cervical intraepithelial neoplasia |
| Date of disclosure of the study information | 2013/04/03 |
| Last modified on | 2019/04/09 10:33:11 |
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Basic information
Public title
Efficacy of photodynamic therapy (PDT) of 5-Aminolevulinic Acid for cervical intraepithelial neoplasia
Acronym
ALA-PDT
Scientific Title
Efficacy of photodynamic therapy (PDT) of 5-Aminolevulinic Acid for cervical intraepithelial neoplasia
Scientific Title:Acronym
ALA-PDT
Region
| Japan |
Condition
Condition
cervical intraepithelial neoplasia(CIN)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clinical trial to investigate the efficacy and safety of PDT using 5-aminolevrinic acid (ALA),in patients with cervical intraepithelial neoplasia (CIN).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
efficacy (rate of complete response)
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
CIN3
Interventions/Control_2
CIN1/2
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 3 months by Central Pathological Review
2) 2groups I)CIN3 II)CIN1/2
3) 20-50years-old
4) ECOG Performance Status (PS)0-2
5) Patients with organ function is maintained sufficiently
6) Patients consent of patients was obtained in writing
7) A outpatient
Key exclusion criteria
1) Patients (including tuberculosis activities)
uncontrolled infection.
2) Patients with severe underlying disease (Malignant hypertension. With severe congestive heart failure. Severe liver failure. Myocardial infarction within 3 months. End-stagecirrhosis. Poorly controlled diabetes. Severe pulmonary fibrosis. Interstitial pneumonia activity)
3) Allogeneic bone marrow transplantation
4) Patients with severe mental disorders
5) Patients with porphyria or hypersensitivity to porphyrins allergy
6) A gravida, a lactational woman
7) Patients with severe anemiallegy
8) Patients were deemed inappropriate by
research investigators
9) Patients with CIN1 within 2years
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Mizuno |
Organization
Aichi cancer center
Division name
Department of Gynecology
Zip code
4648681
Address
1-1 kanokoden chikusa-ku Nagoya
TEL
052-762-6111
mizunomizuno@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Mizuno |
Organization
Aichi cancer center
Division name
Department of Gynecology
Zip code
4648681
Address
1-1 kanokoden chikusa-ku Nagoya
TEL
052-744-2261
Homepage URL
mizunomizuno@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of
Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University
Address
65 Tsuruma-cho, Showa-ku, Nagoya 466- 8550
Tel
052-744-2261
shiro-s@med.nagoya-u.ac.jp
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
| 2013 | Year | 04 | Month | 03 | 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
Main results already published
Date of protocol fixation
| 2012 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 03 | Day |
Last modified on
| 2019 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012090
