UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018548 |
|---|---|
| Receipt number | 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 | 2025/02/10 15:49:06 |
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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 | Eigo |
| Middle name | |
| Last name | Otsuji |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Digestive Surgery, Department of Surgery
Zip code
6028566
Address
465 Kajii-cho, Kamigyo-ku Kyoto 6028566 JAPAN
TEL
075-251-5527
otsuji@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yasutoshi |
| Middle name | |
| Last name | Murayama |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Digestive Surgery, Department of Surgery
Zip code
6028566
Address
465 Kajii-cho, Kamigyo-ku Kyoto 6028566 JAPAN
TEL
075-251-5527
Homepage URL
murayama@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kamigyo-ku Kyoto 6028566 JAPAN
Tel
075-251-5527
murayama@koto.kpu-m.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
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
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021012
