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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032500
Receipt No. R000036455
Scientific Title Development of photodynamic diagnosis of thoracic malignant tumors with 5-aminolevulinic acid
Date of disclosure of the study information 2018/05/10
Last modified on 2018/05/07

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Basic information
Public title Development of photodynamic diagnosis of thoracic malignant tumors with 5-aminolevulinic acid
Acronym Photodynamic diagnosis with 5-aminolevulinic acid
Scientific Title Development of photodynamic diagnosis of thoracic malignant tumors with 5-aminolevulinic acid
Scientific Title:Acronym Photodynamic diagnosis with 5-aminolevulinic acid
Region
Japan

Condition
Condition thoracic malignant tumor
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To improve the precision of photodynamic diagnosis of thoracic malignant tumor and lymph node metastasis with combination of 5-aminolevulinic acid.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement the rate of photodynamic diagnosis of thoracic malignant tumor progression
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 5-ALA-HCl dissolved in orange juice is administered orally, 5 hours prior to induction of anesthesia.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patient who have thoracic malignant tumor(lung cancer, metastatic lung tumor, malignant pleura tumor, thoracic lymph node metastasis of breast cancer)
2)Surgical patient who have thoracic malignant tumor, diagnosed with image or pathology
3)Patient who need diagnosis with video assisted thoracic surgery
4)Patient who comprehend this clinical trial and written conscent after receive an explanation
Key exclusion criteria 1)Pregnant or breast-feeding
2)Porphyria
3)Patient who take drugs or food including an ingredient that becomes photo sensitivity, for example, tetracyclines, sulfonamides, new quinolones, hypericines(extract St. John's wort), foods include St. John's wort, etc.
4)Chronic hepatitis or chronic kidney disease
5)No treatment plan changing by this trial
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Ohsaki
Organization Asahikawa Medical University Hospital
Division name Department of Respiratory Center
Zip code
Address Midorigaoka-Higashi 2-1-1-1 Asahikawa Hokkaido Japan 078-8510
TEL 0166-69-3290
Email yohsaki@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Kitada
Organization Asahikawa Medical University Hospital
Division name Department of Respiratory Center
Zip code
Address Midorigaoka-Higashi 2-1-1-1 Asahikawa Hokkaido Japan 078-8510
TEL 0166-69-3290
Homepage URL
Email k1111@asahikawa-med.ac.jp

Sponsor
Institute Ministry of Education
Institute
Department

Funding Source
Organization Ministry of Education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 05 Month 10 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 03 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing particular

Management information
Registered date
2018 Year 05 Month 07 Day
Last modified on
2018 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036455

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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