UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Basic research aiming for clinical application of 5-aminolevulinic acid in musculoskeletal sarcomas
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Jungo Imanishi
Organization	Saitama Medical University International Medical Center
Division name	Orthopaedic Oncology and Surgery
Address	1397-1 Yamane, Hidaka, Saitama 350-1298, JAPAN
TEL	042-984-4111
Email	jungo@saitama-med.ac.jp

Public contact
Name of contact person	Jungo Imanishi
Organization	Saitama Medical University International Medical Center
Division name	ORthopaedic Oncology and Surgery
Address	1397-1 Yamane, Hidaka, Saitama 350-1298, JAPAN
TEL	042-984-4111
Homepage URL
Email	jungo@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University International Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025667