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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039304
Receipt No. R000044829
Scientific Title Study on cancer risk assessment method using 5-aminolevulinic acid
Date of disclosure of the study information 2020/01/29
Last modified on 2020/01/29

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Basic information
Public title Study on cancer risk assessment method using 5-aminolevulinic acid
Acronym cancer risk assessment method using 5-aminolevulinic acid
Scientific Title Study on cancer risk assessment method using 5-aminolevulinic acid
Scientific Title:Acronym cancer risk assessment method using 5-aminolevulinic acid
Region
Japan

Condition
Condition Lung cancer, colon cancer, stomach cancer, breast cancer
Classification by specialty
Surgery in general Gastrointestinal surgery Chest surgery
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Cancer that causes metabolic dysfunction by taking 5-aminolevulinic acid phosphate and detecting porphyrins, that are not excreted as urinary metabolites if metabolic functions in normal cells, assess the degree of cancer risk.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Analysis of the accuracy of 5-aminolevulinic acid as a cancer risk assessment index
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 Historical
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Oral administration of 5-aminolevulinic acid phosphate 150 mg once at night
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 Male and Female
Key inclusion criteria 1) Cancer patients 20 years or older (male, female)
2) Patients diagnosed with the target carcinoma (lung cancer, stomach cancer, colon cancer, breast cancer)
3) Patients who do not have different primary tumors other than the target 4 carcinomas
4) Patients whose target carcinoma is recognized by CT, MRI, ultrasound, etc.
5) Inpatients
6) Patients who have given written consent to participate in this study
7) Patients who have not been treated with high-concentration vitamin C therapy or hyperthermia, radiation, or other phototherapy combined with 5ALA in the period one month before urine collection
8) Patients who can stop drugs, supplements, drinking, smoking, etc. on the day of urine collection
Key exclusion criteria 1) Patients with a history or diagnosis of porphyria
2) Pregnant women or patients who may become pregnant or breastfeeding
3) Patients who have difficulty in filling in the consent form or have problems with the urine collection procedure due to psychiatric complications, etc.
4) Patients with primary tumors other than the target 4 carcinomas
5) Patients who underwent high-concentration vitamin C therapy or treatment with 5-ALA, such as heat, radiation, or other phototherapy, one month before urine collection
6) Patients with severe cardiovascular disease, lung, liver, or kidney disease who are undergoing treatment or are at risk for it
7) Patients who are required to prescribe drugs separately prescribed on the day of urine collection
8) Other patients who are judged inappropriate by the doctor's judgment
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Masafumi
Middle name
Last name Kawamura
Organization Teikyo University School of medicine
Division name Department of surgery
Zip code 173-8605
Address Kaga 2-11-1, Itabashi, Tokyo, Japan
TEL 03-3964-1211
Email mkawamur@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name Yoshikane
Middle name
Last name Yamauchi
Organization Teikyo University School of medicine
Division name Department of surgery
Zip code 173-8605
Address Kaga 2-11-1, Itabashi, Tokyo, Japan
TEL 03-3964-1211
Homepage URL
Email yoshikaney@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University School of medicine
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Teikyo University Ethics committee
Address Kaga 2-11-1, Itabashi, Tokyo, Japan
Tel 03-3964-7256
Email turb-office@teikyo-u.ac.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

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 29 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 01 Month 16 Day
Date of IRB
2018 Year 01 Month 16 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 29 Day
Last modified on
2020 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044829

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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