UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Cohort Study: Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials
Acronym	Prospective Cohort Study: Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials (SELECT BC ECO)
Scientific Title	Prospective Cohort Study: Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials
Scientific Title:Acronym	Prospective Cohort Study: Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials (SELECT BC ECO)
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To prospectively perform a prognostic study of participants and participation-refusers of SELECT BC 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	Others
Key secondary outcomes	Overall Survival

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 months-old <=
Age-upper limit	75 months-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, to all patients who received the participation description of the present study after the start SELECT BC interest. The definition of the nonparticipation patients are those who satisfied with the csse selection criteria of the SELECT BC, though expressed refusal to participate in SELECT BC. (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) The patient has breast cancer that has worsened or recurred in association with distant metastasis after treatment (after surgery and preoperative and postoperative treatment); however, local recurrence is excluded.
Key exclusion criteria	(i) Women who are pregnant, nursing infants or intend to become pregnant. (ii) Overexpression of HER2 (Her2/neu, Erb B2), or the results of fluorescence in situ hybridization are positive.
Target sample size	68

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinji Ohno
Organization	The Cancer Institute Hospital of JFCR
Division name	Breast Oncology Center
Zip code
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 Middle name Last name Akira Yamao
Organization	Public Health Reserchi Foundation
Division name	Comprehensive Support Project for Clinical Research
Zip code
Address	Nishiwaseda1-1-7, Shinjyuku-ku Tokyo, 169 -0051 Japan
TEL	03-5287-2633
Homepage URL	http://www.csp.or.jp/
Email	cspor-office@csp.or.jp

Sponsor
Institute	SELECT BC executive committee
Institute
Department

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
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 20 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	68
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	2009 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date	2009 Year 08 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2015 Year 11 Month 02 Day

Other

Other related information

The study design:Prospective Cohort Study At the time of registration with respect to SELECT BC participants, as well as carry out the follow-up survey after the protocol treatment. And registered in the data center as a decline in the cases declined cases Registration Form consists of almost the same items and SELECT BC participants at the time of registration with respect to participation declined cases, then investigate the treatment of post-registration and survival (1 to 3-line treatment) to. SELECT BC trial UMIN ID:C000000416

Management information
Registered date	2016 Year 01 Month 20 Day
Last modified on	2020 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023829