UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039304 |
|---|---|
| Receipt number | 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 | 2024/08/02 09:30:15 |
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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
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
yoshikaney@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of medicine
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2024 | 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
| 2024 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044829
