UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032048
Receipt number R000021969
Scientific Title Diagnosis of gastric cancer by measuring the urinary porphyrins after oral administration of 5-aminolevulinic acid (ALA).
Date of disclosure of the study information 2018/04/01
Last modified on 2019/04/02 16:38:57

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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

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

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 or person

Institute

Osaka Police Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021969


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name