UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020574 |
|---|---|
| Receipt number | 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 09:16:24 |
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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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023754
