UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025295 |
|---|---|
| Receipt number | R000029095 |
| Scientific Title | Detection of early breast cancer by peptide mass spectrometry (BLOTCHIP(R)-MS method) |
| Date of disclosure of the study information | 2016/12/15 |
| Last modified on | 2019/12/18 15:40:02 |
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Basic information
Public title
Detection of early breast cancer by peptide mass spectrometry (BLOTCHIP(R)-MS method)
Acronym
Detection of early breast cancer by BLOTCHIP(R)-MS method
Scientific Title
Detection of early breast cancer by peptide mass spectrometry (BLOTCHIP(R)-MS method)
Scientific Title:Acronym
Detection of early breast cancer by BLOTCHIP(R)-MS method
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the group of peptides specifically expressed in patient sera using the BLOTCHIP (R) -MS method and to develop novel biomarkers of early breast cancer
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Accuracy of breast cancer diagnosis of serum peptide biomarker identified by peptide mass spectrometry
Key secondary outcomes
Correlation with breast cancer clinical stage, tumor marker, therapeutic significance of identified peptide markers
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Breast cancer patients
2. Cases without breast cancer as a control group
Key exclusion criteria
1. Pregnant
2. Pretreated patient
3. Double cancer
4. Unqualified patient
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Sakaguchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Endocrine and Breast Surgery
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL
075-251-5534
ksak@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Sakaguchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Endocrine and Breast Surgery
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL
075-251-5534
Homepage URL
ksak@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Protosera Inc.
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 | 12 | Month | 15 | 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
| 2016 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 12 | Month | 15 | Day |
Last modified on
| 2019 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029095
