Unique ID issued by UMIN | UMIN000020645 |
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Receipt number | 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 11:49:54 |
Prospective Cohort Study:
Whether or Not Patients Benefit
From Participation Itself in Randomized-controlled Trials
Prospective Cohort Study:
Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials
(SELECT BC ECO)
Prospective Cohort Study:
Whether or Not Patients Benefit
From Participation Itself in Randomized-controlled Trials
Prospective Cohort Study:
Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials
(SELECT BC ECO)
Japan |
Breast Cancer
Breast surgery |
Malignancy
NO
To prospectively perform a prognostic study of participants and participation-refusers of SELECT BC
trials to compare their life prognoses
Others
At randomize it itself tests participation
Will it be the profit by a point of the convalescence?
Confirmatory
Pragmatic
Not applicable
Others
Overall Survival
Observational
20 | months-old | <= |
75 | months-old | >= |
Female
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.
(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.
68
1st name | |
Middle name | |
Last name | Shinji Ohno |
The Cancer Institute Hospital of JFCR
Breast Oncology Center
3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan
+81-3-3520-0111
shinji.ohno@jfcr.or.jp
1st name | |
Middle name | |
Last name | Akira Yamao |
Public Health Reserchi Foundation
Comprehensive Support Project for Clinical Research
Nishiwaseda1-1-7, Shinjyuku-ku Tokyo, 169 -0051 Japan
03-5287-2633
http://www.csp.or.jp/
cspor-office@csp.or.jp
SELECT BC executive committee
Public Health Research Foundation
Non profit foundation
Japan
NO
2016 | Year | 01 | Month | 20 | Day |
Published
68
Completed
2009 | Year | 08 | Month | 05 | Day |
2009 | Year | 08 | Month | 26 | Day |
2015 | Year | 11 | Month | 02 | Day |
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
2016 | Year | 01 | Month | 20 | Day |
2020 | Year | 02 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023829
Research Plan | |
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Research case data specifications | |
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Registered date | File name |
Research case data | |
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