UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027996 |
|---|---|
| Receipt number | R000032062 |
| Scientific Title | Feasibility study of photodynamic diagnosis using 5-aminolaevulinic acid during endoscopic submucosal dissection for early gastric cancer |
| Date of disclosure of the study information | 2017/07/07 |
| Last modified on | 2021/05/05 09:49:32 |
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Basic information
Public title
Feasibility study of photodynamic diagnosis using 5-aminolaevulinic acid during endoscopic submucosal dissection for early gastric cancer
Acronym
PDD using 5ALA for early gastric cancer
Scientific Title
Feasibility study of photodynamic diagnosis using 5-aminolaevulinic acid during endoscopic submucosal dissection for early gastric cancer
Scientific Title:Acronym
PDD using 5ALA for early gastric cancer
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the feasibility of photodynamic diagnosis using 5-aminolevulinic acid to identify gastric cancer during endoscopic submucosal dissection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy
Key secondary outcomes
Adverse events
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
Before endoscopic submucosal dissection, 20 mg/m2 of 5-aminolevulinic acid solution was given orally. After tumor resection, resected specimens were investigated by an endoscopic phododynamic diagnosis system, and red fluorescence-positive lesions were compared with the pathological result.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. An age of 20 years and over.
2. Histologically proven intestinal type gastric adenocarcinoma including papillary, well and moderate differentiated adenocarcinoma.
3. A performance status of 0-1 accord
ing to the Eastern Cooperative Oncol
ogy Group (ECOG) scale.
4. Adequate organ function including heart, lung, liver, kidney and bone marrow function in addition to clinical laboratory results.
5. Patients without synchronous or metachronous malignant disease, or multicentric cancer.
6. All patients gave written informed
consent.
9. All patients gave written
Key exclusion criteria
1. Uncontrollable infectious disease including active tuberculosis.
2. Serious concurrent disease such as
malignant hypertension, severe congestive heart failure, severe coronary ischemic disease, acute myocardial infarction, terminal liver cirrhosis, severe renal insufficiency, dialysis patients, uncontrollable diabetes mellitus, severe pulmonary fibrosis, interstitial pneumonia and so on.
3. Patients received bone marrow transplantation.
4. Patients with psychosomatic disorder.
5. Patients with porphyria or hypersensitivity to porphyrins allergy.
6. Women who are pregnant or hope
to become pregnant during the study
period.
7. Patients judged inappropriate for t
he study by their physicians.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu Namikawa |
| Middle name | |
| Last name | Tsutomu Namikawa |
Organization
Kochi Medical School
Division name
Department of Surgery
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL
+81-88-880-2370
tsutomun@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu Namikawa |
| Middle name | |
| Last name | Tsutomu Namikawa |
Organization
Kochi Medical School
Division name
Department of Surgery
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL
+81-88-880-2370
Homepage URL
http://www.kochi-ms.ac.jp/~fm_srgr1/index.html
tsutomun@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Department of Surgery, Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku, Kochi
Tel
088-880-2370
tsutomun@kochi-u.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 07 | 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
2
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 29 | Day |
Last modified on
| 2021 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032062
| 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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| Registered date | File name |
