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

Email

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


Email

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012090


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name