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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020574
Receipt No. R000023754
Scientific Title The study of evaluation that primary tumor resection influences to circulating tumor cells on Stage IV breast cancer(JCOG1017-A1)
Date of disclosure of the study information 2016/01/14
Last modified on 2017/01/18

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Basic information
Public title The study of evaluation that primary tumor resection influences to circulating tumor cells on Stage IV breast cancer(JCOG1017-A1)
Acronym The study of evaluation that primary tumor resection influences to circulating tumor cells on Stage IV breast cancer(JCOG1017-A1)
Scientific Title The study of evaluation that primary tumor resection influences to circulating tumor cells on Stage IV breast cancer(JCOG1017-A1)
Scientific Title:Acronym The study of evaluation that primary tumor resection influences to circulating tumor cells on Stage IV breast cancer(JCOG1017-A1)
Region
Japan

Condition
Condition metastatic brest cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the effect that primary tumor resection gives to circulating tumor cells exploratorily on Stage IV breast cancer
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes CTC-positive ratio, CTC-positive sustained ratio
Key secondary outcomes CTC decrement, CTC decrease ratio

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 A: Systemic therapy alone
Interventions/Control_2 B: Primary tumor resection plus systemic therapy
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 Female
Key inclusion criteria 1)first registration to JCOG1017
2)Within 14 days from the date of second registration
3)Witten informed consent
Key exclusion criteria no exclusion criteria at second registration
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroji Iwata
Organization Aichi Cancer Center Hospital
Division name Department of Breast Oncology
Zip code
Address 1-1, Kanokoden, Chikusa-ku, Nagoya 464-8661, Japan
TEL 052-762-6111
Email hiwata@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoto Kondo
Organization Naogya City University
Division name Department of Oncology , Immunology & Surgery
Zip code
Address 1 Kawasumi,Mizuho-cho,Mizuho-ku,Naogya 467-8601,Japan
TEL 052-853-8231
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
2016 Year 01 Month 14 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
2015 Year 06 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 13 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 01 Month 14 Day
Last modified on
2017 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023754

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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