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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020645
Receipt No. R000023829
Scientific Title Prospective Cohort Study: Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials
Date of disclosure of the study information 2016/01/20
Last modified on 2020/02/21

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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