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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025295
Receipt No. 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 2018/10/10

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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
Email 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
Email ksak@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
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
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 No longer recruiting
Date of protocol fixation
2016 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2016 Year 12 Month 15 Day
Last modified on
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029095

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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