UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of New Diagnostic Method for Lymph Nodes Using 5-Aminolevulinic Acid in Uterine endometrial Patients.
Title of the study (Brief title)	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	Jo Kitawaki
Organization	Kyoto Prefectural University of Medicine
Division name	Obstetrics and Gynecology
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	Taisuke Mori
Organization	Kyoto Prefectural University of Medicine
Division name	Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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