UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023350 |
|---|---|
| Receipt number | R000026315 |
| Scientific Title | Prospective study of protoporphyrin IX fluorescence and spectral detection in digestive malignant tumors |
| Date of disclosure of the study information | 2016/07/27 |
| Last modified on | 2016/10/18 05:29:38 |
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Basic information
Public title
Prospective study of protoporphyrin IX fluorescence and spectral detection in digestive malignant tumors
Acronym
Prospective study of protoporphyrin IX fluorescence and spectral detection in digestive malignant tumors
Scientific Title
Prospective study of protoporphyrin IX fluorescence and spectral detection in digestive malignant tumors
Scientific Title:Acronym
Prospective study of protoporphyrin IX fluorescence and spectral detection in digestive malignant tumors
Region
| Japan |
Condition
Condition
digestive malignant tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We examine the utility of endoscopic detection for digestive malignant tumors by using protoporphyrin IX fluorescence and endemism spectral detection, which accumulates selectively after 5-ALA administration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The detection rate for malignant tumors by using protoporphyrin IX fluorescence and endemism spectral detection
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
2days
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Age of patients at start of the trial is 20 years or older
2) Patients with digestive malignant tumors with the need of pathological diagnosis before treatment
Key exclusion criteria
1) Patients with porphyrinemia
2) Patients with hypersensitivity or a medical history with porphyrin related adverse events
3) People who have taken chemotheraphy for malignant tumors within one month before the start of the trial
4) Patients who have had other cancers
5) Patients who are taking anticoagulant or antithrombotic drugs
6) Women who are pregnant or are possibly pregnant
7) Patients with positive HBs antigen or HCV antibody
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Matsumoto |
Organization
Department of Multidisciplinary Internal Medicine Faculty of Medicine,Tottori University
Division name
Division of Medicine and Clinical Science
Zip code
Address
36-1 Nishi-cho, Yonago 683-8504, Japan.
TEL
0859-38-6527
matsumot@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Kurumi |
Organization
Department of Multidisciplinary Internal Medicine Faculty of Medicine,Tottori University
Division name
Division of Medicine and Clinical Science
Zip code
Address
36-1 Nishi-cho, Yonago 683-8504, Japan.
TEL
0859-38-6527
Homepage URL
kurumi_1022_1107@yahoo.co.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 07 | Month | 27 | 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
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 30 | 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
| 2016 | Year | 07 | Month | 27 | Day |
Last modified on
| 2016 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026315
