UMIN-CTR Clinical Trial

Basic information
Public title	Diagnosis of gastric cancer by measuring the urinary porphyrins after oral administration of 5-aminolevulinic acid (ALA).
Acronym	Diagnosis of gastric cancer using urinary porphyrins.
Scientific Title	Diagnosis of gastric cancer by measuring the urinary porphyrins after oral administration of 5-aminolevulinic acid (ALA).
Scientific Title:Acronym	Diagnosis of gastric cancer using urinary porphyrins.
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine whether the urinary levels of porphyrins after oral administration of 5-ALA are potential marker for diagnosis of gastric cancer.
Basic objectives2	Others
Basic objectives -Others	Study of the measurement method
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The urinary and serum levels of porphyrins (5-ALA, uroporphyrin I and III, coproporphyrin I and III, protoporphyrin IX) after oral administration of 5-ALA in gastric cancer patients before and after gastrectomy and non-cancer patients.
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Measuring the urinary and serum levels of porphyrins after oral administration of 5-ALA (300mg) at the following points. 1. Gastric cancer patients 30 cases 1) before gastrectomy 2) after gastrectomy 3) every 6 months after gastrectomy 2. non-cancer patients 10 cases
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) >=20 years old, <85 years old 2) Gastrectomy is scheduled for cSE gastric cancer. 3) patients who provide a written informed consent
Key exclusion criteria	1) Patients with severe anamnesis (Malignant hypertension. With severe congestive heart failure. Severe liver failure. Myocardial infarction within 3 months. End-stage cirrhosis. Poorly controlled diabetes. Severe pulmonary fibrosis. Interstitial pneumonia activity) 2) Patients who are able to orally intake foods. 3) Patients with porphyria or hypersensitivity to porphyrins allergy 4) Cancer patients within 5 years after treatment.
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Hiroki Middle name Last name Akamatsu
Organization	Osaka Police Hospital
Division name	Department of gastrointestinal surgery
Zip code	543-0035
Address	10-31 Kitayama-cho, Tennoji-ku, Osaka, Japan
TEL	06-6771-6051
Email	h.akamatsu@me.com

Public contact
1st name of contact person	1st name Kentaro Middle name Last name Kishi
Organization	Osaka Police Hospital
Division name	Department of gastrointestinal surgery
Zip code	543-0035
Address	10-31 Kitayama-cho, Tennoji-ku, Osaka, Japan
TEL	06-6771-6051
Homepage URL
Email	kishi-ke@oph.gr.jp

Sponsor
Institute	Osaka Police Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Drug supply and Sample measurement: SBI Phamaceuticals Co., Ltd
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka Police Hospital
Address	10-31 Kitayama-cho, Tennoji-ku, Osaka, Japan
Tel	0667716051
Email	shomu@oph.gr.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	大阪警察病院

Other administrative information
Date of disclosure of the study information	2018 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	Completed
Date of protocol fixation	2015 Year 04 Month 30 Day
Date of IRB	2015 Year 05 Month 12 Day
Anticipated trial start date	2015 Year 09 Month 15 Day
Last follow-up date	2019 Year 03 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 01 Day
Last modified on	2019 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021969