UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020248 |
|---|---|
| Receipt number | R000023378 |
| Scientific Title | Development of rapid detection methods on cancer-related components in blood and body fluid samples from cancer patients |
| Date of disclosure of the study information | 2015/12/17 |
| Last modified on | 2017/04/11 07:28:02 |
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Basic information
Public title
Development of rapid detection methods on cancer-related components in blood and body fluid samples from cancer patients
Acronym
Development of rapid detection methods on cancer-related components in blood and body fluid samples from cancer patients
Scientific Title
Development of rapid detection methods on cancer-related components in blood and body fluid samples from cancer patients
Scientific Title:Acronym
Development of rapid detection methods on cancer-related components in blood and body fluid samples from cancer patients
Region
| Japan |
Condition
Condition
Cancer (positive control) and benign diseases (negative control)
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Development of rapid detection methods on cancer-related components in blood and body fluid samples from patients with cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative detection of cancer-related components in blood and body fluid samples from patients with cancer and benign disease.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients with histologically proven cancer and benign disease patients without cancer who are treated in Showa University Koto Toyosu Hospital and Ryukyu University Hospital since 2015.
(2) Clinical solitary tumor (cancer patients)
(3) No prior treatment
(4) Age 20-80 years
(5) Eastern Cooperative Oncology Group performance status 0 or 1
(6) Sufficient organ function
(7) Written informed consent
Key exclusion criteria
(1) Synchronous or metachronous malignancy
(2) Pregnant or breastfeeding women
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ito, MD, PhD |
Organization
Showa University Koto-Toyosu Hospital
Division name
Digestive Disease Center
Zip code
Address
5-1-38 Toyosu, Koto-ku, Tokyo 135-8577 Japan
TEL
03-6204-6000
h.ito@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ito, MD, PhD |
Organization
Showa University Koto-Toyosu Hospital
Division name
Digestive Disease Center
Zip code
Address
5-1-38 Toyosu, Koto-ku, Tokyo 135-8577 Japan
TEL
03-6204-6000
Homepage URL
h.ito@med.showa-u.ac.jp
Sponsor or person
Institute
Digestive Disease Center, Showa University Koto-Toyosu Hospital
Institute
Department
Personal name
Funding Source
Organization
Digestive Disease Center, Showa University Koto-Toyosu Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 12 | Month | 17 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 28 | Day |
Other
Other related information
Prospective study.
Blind blood serum samples from patients with histologically proven cancer and benign disease patients without cancer who are treated in Showa University Koto Toyosu Hospital and Ryukyu University Hospital since 2015 will be prospectively analyzed by using the bio-chip (Proteo). We will detect a surface-enhanced Raman scattering and autofluorescence to distinguish cancer patients from non-cancer patients.
Management information
Registered date
| 2015 | Year | 12 | Month | 17 | Day |
Last modified on
| 2017 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023378
| 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 |
