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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027996
Receipt No. 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 2017/06/29

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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
Middle name
Last name Tsutomu Namikawa
Organization Kochi Medical School
Division name Department of Surgery
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL +81-88-880-2370
Email tsutomun@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Namikawa
Organization Kochi Medical School
Division name Department of Surgery
Zip code
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
Email tsutomun@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
Institute
Department

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
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
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
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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 07 Day
Last follow-up date
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
2017 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032062

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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