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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023436
Receipt No. R000025932
Scientific Title Development of New Diagnostic Method for Lymph Nodes Using 5-Aminolevulinic Acid in Uterine endometrial Patients.
Date of disclosure of the study information 2016/10/01
Last modified on 2016/08/01

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Basic information
Public title Development of New Diagnostic Method for Lymph Nodes Using 5-Aminolevulinic Acid in Uterine endometrial Patients.
Acronym Development of New Diagnostic Method for Lymph Nodes Using 5-Aminolevulinic Acid in Uterine endometrial Patients.
Scientific Title Development of New Diagnostic Method for Lymph Nodes Using 5-Aminolevulinic Acid in Uterine endometrial Patients.
Scientific Title:Acronym Development of New Diagnostic Method for Lymph Nodes Using 5-Aminolevulinic Acid in Uterine endometrial Patients.
Region
Japan

Condition
Condition Uterine endometrial cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop a novel diagnostic method for detecting lymph node metastasis in endometrial cancer. To confirm the safety of 5-aminolevulinic acid (5-ALA) and efficacy of the measurement function for endoemtrial cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes To confirm the safety of 5-ALA and the performance of the measuring instrument.
To check the matching rate between 5-ALA method and rapid or permanent pathological diagnosis.
Key secondary outcomes

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 Diagnosis
Type of intervention
Medicine
Interventions/Control_1 5-aminolevulinic acid
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

Not applicable
Gender Female
Key inclusion criteria 1. Age older than 20 years
2 .Diagnosed with operable endometrial cancer
3. Informed consent is signed
Key exclusion criteria 1. Porphyria
2. With history of hypersensitivity reaction for 5-aminolevulinic acid or porphyrin
3. For whom drugs that can cause photosensitivity disease is needed
4. Apparently or possibly pregnant or have desire to be come pregnant
5. Cases who physician judged improper to entry this trial
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jo Kitawaki
Organization Kyoto Prefectural University of Medicine
Division name Obstetrics and Gynecology
Zip code
Address 465 Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto
TEL +81-75-251-5560
Email aoi@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taisuke Mori
Organization Kyoto Prefectural University of Medicine
Division name Obstetrics and Gynecology
Zip code
Address 465 Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto
TEL +81-75-251-5560
Homepage URL
Email aoi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Other
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 10 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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 10 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
2016 Year 08 Month 01 Day
Last modified on
2016 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025932

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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