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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018548
Receipt No. R000021012
Scientific Title Development of the new diagnostic method of resection stump and lymph node metastases in gastric cancer patients using 5-ALA.
Date of disclosure of the study information 2015/08/05
Last modified on 2019/08/14

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Basic information
Public title Development of the new diagnostic method of resection stump and lymph node metastases in gastric cancer patients using 5-ALA.
Acronym Diagnosis o fresection stump and lymph node metastases in gastric cancer patients using 5-ALA.
Scientific Title Development of the new diagnostic method of resection stump and lymph node metastases in gastric cancer patients using 5-ALA.
Scientific Title:Acronym Diagnosis o fresection stump and lymph node metastases in gastric cancer patients using 5-ALA.
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate a real time diagnostic performance of lymph node metastasis of gastric cancer using 5-aminolevulinic acid.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Sensitivity and specificity of lymph node metastasis using fluorescence diagnostics
Key secondary outcomes The comparison to the difference in fluorescence between normal and metastatic lymph nodes,
Positive predictive value,
Negative predictive value

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 Fluorescence diagnosis using 5-ALA of resected lymph nodes of gastric cancer will be studied. Patients received a dose at 20 mg per kg body weight of 5-ALA 3 hours prior to surgery. We compare fluorescence diagnosis and pathological diagnosis.
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 Patients have a malignant tumor lesions in the stomach
Patients who provided signed informed consent
Key exclusion criteria Porphyria
Patients with a history of hypersensitivity of 5-ALA or porphyrins
Patients taking drugs that may cause photosensitivity (tetracycline antibiotics, sulfonamide-based formulation, new quinolone antibiotics, hypericin, St. John's wort-containing foods, etc)
Patients who is or might be pregnant
Patients who is determined inappropriate to participate in the study by the attending physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eigo Otsuji
Organization Kyoto Prefectural University of Medicine
Division name Division of Digestive Surgery, Department of Surgery
Zip code
Address 465 Kajii-cho, Kamigyo-ku Kyoto 6028566 JAPAN
TEL 075-251-5527
Email otsuji@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasutosi Murayama
Organization Kyoto Prefectural University of Medicine
Division name Division of Digestive Surgery, Department of Surgery
Zip code
Address 465 Kajii-cho, Kamigyo-ku Kyoto 6028566 JAPAN
TEL 075-251-5527
Homepage URL
Email murayama@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Ushio Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor Ushio Ltd.
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 京都府立医科大学附属病院 (京都府)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 05 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
2015 Year 05 Month 31 Day
Date of IRB
2015 Year 05 Month 31 Day
Anticipated trial start date
2015 Year 07 Month 31 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 05 Day
Last modified on
2019 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021012

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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