UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022275 |
|---|---|
| Receipt number | R000025667 |
| Scientific Title | Basic research aiming for clinical application of 5-aminolevulinic acid in musculoskeletal sarcomas |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2016/05/11 15:54:53 |
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Basic information
Public title
Basic research aiming for clinical application of 5-aminolevulinic acid in musculoskeletal sarcomas
Acronym
Basic research aiming for clinical application of 5-ALA in musculoskeletal sarcomas
Scientific Title
Basic research aiming for clinical application of 5-aminolevulinic acid in musculoskeletal sarcomas
Scientific Title:Acronym
Basic research aiming for clinical application of 5-ALA in musculoskeletal sarcomas
Region
| Japan |
Condition
Condition
bone and soft tissue sarcomas
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
1. To clarify whether 5-ALA is clinically applicable in musculoskeletal sarcomas by measuring fluorescent signal induced by 5-ALA in both cell lines and frozen clinical specimens after 5-ALA administration.
2. To clarify problems in clinical application of 5-ALA for musculoskeletal sarcomas by screening and analyzing genes related to intra-cellular accumulation of protoporphyrin IX (PPIX) accumulation in both cell lines and clinical specimens.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The strength of fluorescent signal induced by PPIX in both cell lines and clinical specimens
Key secondary outcomes
2. The degree of expression of the aforementioned genes in both cell lines and clinical specimens
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
The administration of 5-aminolevulinic acid (5-ALA)
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
Diagnosed as bone or soft tissue sarcoma
Key exclusion criteria
1. Having difficulty in taking medication
2. Still having severe adverse effects of previous treatment for sarcomas
3. Having un-controlled infection
4. Severe complications, such as malignant hypertension, severe congestive heart failure, myocardial infarction within 3 months, terminal cirrhosis, un-controlled diabetes, severe pulmonary fibrosis, active interstitial pneumonia
5. Allergy to porphyrin-related substances
6. Porphyria
7. Other active cancer including hematologic malignancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jungo Imanishi |
Organization
Saitama Medical University International Medical Center
Division name
Orthopaedic Oncology and Surgery
Zip code
Address
1397-1 Yamane, Hidaka, Saitama 350-1298, JAPAN
TEL
042-984-4111
jungo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jungo Imanishi |
Organization
Saitama Medical University International Medical Center
Division name
ORthopaedic Oncology and Surgery
Zip code
Address
1397-1 Yamane, Hidaka, Saitama 350-1298, JAPAN
TEL
042-984-4111
Homepage URL
jungo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 11 | Day |
Last modified on
| 2016 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025667
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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