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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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