UMIN-CTR Clinical Trial

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	Obsterics 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
Last 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
Email	mizunomizuno@med.nagoya-u.ac.jp

Public contact
1st 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
Email	mizunomizuno@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012090