UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031433
Receipt number R000035835
Scientific Title 5-aminolevulinic acidphotodynamic therapy for cervical intraepithelial neoplasia
Date of disclosure of the study information 2019/04/01
Last modified on 2018/02/22 23:13:26

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Basic information

Public title

5-aminolevulinic acidphotodynamic therapy for cervical intraepithelial neoplasia

Acronym

5-ALA-PDT for CIN

Scientific Title

5-aminolevulinic acidphotodynamic therapy for cervical intraepithelial neoplasia

Scientific Title:Acronym

5-ALA-PDT for CIN

Region

Japan


Condition

Condition

cervical intraepithelial neoplasia(CIN)

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to investigate safety and efficacy of 5-ALA-PDT in patients with cervical intraepithelial neoplasia

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

safety(topical pain,erosion and overall status):at each PDT and 12 and 24weeks after last PDT

Key secondary outcomes

Complete Response(CR) rate: 12 and 24weeks after last PDT
Treatment time


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

Local administration of aminolevulinic acid jelly 2-3hours before PDT
PDT: irradiation for a red light of 635nm for 3-6minutes (total 100J/m2)

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

50 years-old >

Gender

Female

Key inclusion criteria

1)pathological diagnosis within 3months of the registration of this clinical trial
2)20-50 years-old and premenopausal female
3)ECOG Performance Status(PS) 0-2
4)Patients with organ function is maintained sufficiently
5)Patients with written consent of this clinical trial
6)outpatients

Key exclusion criteria

1)patients with porphyrin hypersensitivity
2)patients with Porphyrias
3)severe drug allergy
4)patients who use a drug causing photosensitivity
5)the patients with other malignant tumors
6)patient with uncontrolled infection
7)patients with myocardial infarction within 6months
8)patients with severe underlying disease
9)patients with severe mental disorders
10)gravida and lactational woman
11)patients judged by investigators as inappropriate to this study

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masato Kita

Organization

Kansai Medical University

Division name

Obstetrics and gynecology

Zip code


Address

2-3-1, Shinmachi, Hirakata-shi, Osaka

TEL

072-804-0101

Email

kitamas@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoji Hisamatsu

Organization

Kansai Medical University

Division name

Obstetrics and gynecology

Zip code


Address

2-3-1, Shinmachi, Hirakata-shi, Osaka

TEL

072-804-0101

Homepage URL


Email

hisamayj@kouri.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical University

Institute

Department

Personal name



Funding Source

Organization

SBI pharmaceutical Co.,Ltd.
Tsukada Medical Reseach Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

関西医科大学付属病院/Kansai Medical University Hospital


Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 01 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

2018 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 04 Month 01 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

2018 Year 02 Month 22 Day

Last modified on

2018 Year 02 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035835


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name