UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021099
Receipt number R000024338
Scientific Title Prospective Cohort Study: Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials 2
Date of disclosure of the study information 2016/02/19
Last modified on 2023/02/27 10:35:33

* 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

Prospective Cohort Study:
Whether or Not Patients Benefit
From Participation Itself in Randomized-controlled Trials 2

Acronym

Prospective Cohort Study:
Whether or Not Patients Benefit
From Participation Itself in Randomized-controlled Trials2
(SELECT BC ECO 2)

Scientific Title

Prospective Cohort Study:
Whether or Not Patients Benefit
From Participation Itself in Randomized-controlled Trials 2

Scientific Title:Acronym

Prospective Cohort Study:
Whether or Not Patients Benefit
From Participation Itself in Randomized-controlled Trials2
(SELECT BC ECO 2)

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Breast surgery Adult

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To prospectively perform a prognostic study of participants and participation-refusers of SELECT BC-CONFIRM trials to compare their life prognoses

Basic objectives2

Others

Basic objectives -Others

At randomize it itself tests participation
Will it be the profit by a point of the convalescence?

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Overall Survival

Key secondary outcomes



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

75 years-old >=

Gender

Female

Key inclusion criteria

This study was carried out as a concomitant study of a randomized controlled study in metastatic or recurrent breast cancer patients SELECT BC-CONFIRM, to all patients who received the participation description of the present study after the start SELECT BC-CONFIRM interest.
The definition of the nonparticipation patients are those who satisfied with the csse selection criteria of the SELECT BC-CONFIRM, though expressed refusal to participate in SELECT BC
-CONFIRM.


(i) Women with a histologically confirmed diagnosis of breast cancer.
(ii) One of the following conditions has to be met for a diagnosis of metastatic breast cancer:
1)At presentation, the patient has distant metastasis.
2) Is an exacerbation or recurrent breast cancer in distant metastasis after treatment. However, local Recurrence is excluded.

Key exclusion criteria

(i) Overexpression of HER2(Her2/neu, Erb B2), or the results of fluorescence in situ hybridization are positive.
(ii) A past history of hypersensitivity to the protocoltreatment drugs or their solvents.
(iii) The presence of other active cancers

Target sample size

44


Research contact person

Name of lead principal investigator

1st name Shinji
Middle name
Last name Ohno

Organization

The Cancer Institute Hospital of JFCR

Division name

Breast Oncology Center

Zip code

135-8550

Address

3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan

TEL

+81-3-3520-0111

Email

shinji.ohno@jfcr.or.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name Yamao

Organization

Public Health Research Foundation

Division name

Comprehensive Support Project for Clinical Research

Zip code

169-0051

Address

Nishiwaseda1-1-7, Shinjyuku-ku Tokyo, 169 -0051 Japan

TEL

03-5287-2636

Homepage URL

http://www.csp.or.jp/

Email

cspor-office@csp.or.jp


Sponsor or person

Institute

SELECT BC-CONFIRM executive committee

Institute

Department

Personal name



Funding Source

Organization

Public Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Kyusyu Cancer Center

Address

3-1-1, Notame, Minami-ku, Fukuoka-shi, Fukuoka 811-1395 Japan

Tel

092-541-3231

Email

jutaku@nk-cc.go.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

2016 Year 02 Month 19 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

Completed

Date of protocol fixation

2011 Year 03 Month 01 Day

Date of IRB

2011 Year 06 Month 14 Day

Anticipated trial start date

2011 Year 06 Month 27 Day

Last follow-up date

2013 Year 12 Month 24 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The study design:Prospective Cohort Study

This study, to FAX the SELECT BC-CONFIRM participation declined cases registration form to the data center. In addition, the treatment of post-survival confirmation and registration of the participants declined's (primary treatment, secondary treatment, tertiary treatment) confirmation of is carried out once after the end of follow-up period of the SELECT BC-CONFIRM.

SELECT BC-CONFIRM trial
UMIN ID :000005449


Management information

Registered date

2016 Year 02 Month 19 Day

Last modified on

2023 Year 02 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024338


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name