UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016999
Receipt number R000018189
Scientific Title Prospective cohort study of lung oligometastasis of breast cancer
Date of disclosure of the study information 2015/03/31
Last modified on 2020/10/03 09:35:40

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Basic information

Public title

Prospective cohort study of lung oligometastasis of breast cancer

Acronym

SBP-06

Scientific Title

Prospective cohort study of lung oligometastasis of breast cancer

Scientific Title:Acronym

SBP-06

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Prospective analysis of diagnosis, treatment strategy and prognosis of lung oligometastasis of breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival of lung oligometastasis of breast cancer

Key secondary outcomes

Efficacy and safety of surgery for lung oligometastasis of breast cancer


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

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)First metastasis after curable breast cancer surgery
(2)under 3 lung metastasesdiagnosed by CT, PET/CT or biposy.
(3)only lung metastasis
(4)ER, PgR and HER2 expression were diagnosed by primary breast cancer tumor

Key exclusion criteria

none

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Tadahiko
Middle name
Last name Shien

Organization

Okayama University Hospital

Division name

Breast and Endocrine surgery

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama

TEL

+81862357265

Email

tshien@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name Tadahiko
Middle name
Last name Shien

Organization

Setouchi Breast Project

Division name

Crinical trial committiee

Zip code

700-8558

Address

2-5-1 Shikata-cho. Kita-ku, Okayama

TEL

086-235-7265

Homepage URL


Email

tshien@md.okayama-u.ac.jp


Sponsor or person

Institute

Setouchi Breast Project

Institute

Department

Personal name



Funding Source

Organization

Setouchi Breast Project

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Okayama University Hospital, Ethics Committee

Address

1-5-2 Shikata-cho, Kita-ku

Tel

086-235-7265

Email

tshien@md.okayama-u.ac.jp


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

2015 Year 03 Month 31 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

2014 Year 10 Month 13 Day

Date of IRB

2014 Year 10 Month 13 Day

Anticipated trial start date

2014 Year 10 Month 13 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Diagnosis, treatment strategy and prognosis of lung oligometastasis of breast cancer


Management information

Registered date

2015 Year 03 Month 31 Day

Last modified on

2020 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018189


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name