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 |
Prospective Cohort Study:
Whether or Not Patients Benefit
From Participation Itself in Randomized-controlled Trials 2
Prospective Cohort Study:
Whether or Not Patients Benefit
From Participation Itself in Randomized-controlled Trials2
(SELECT BC ECO 2)
Prospective Cohort Study:
Whether or Not Patients Benefit
From Participation Itself in Randomized-controlled Trials 2
Prospective Cohort Study:
Whether or Not Patients Benefit
From Participation Itself in Randomized-controlled Trials2
(SELECT BC ECO 2)
Japan |
Breast Cancer
Breast surgery | Adult |
Malignancy
YES
To prospectively perform a prognostic study of participants and participation-refusers of SELECT BC-CONFIRM 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
Overall Survival
Observational
20 | years-old | <= |
75 | years-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-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.
(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
44
1st name | Shinji |
Middle name | |
Last name | Ohno |
The Cancer Institute Hospital of JFCR
Breast Oncology Center
135-8550
3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan
+81-3-3520-0111
shinji.ohno@jfcr.or.jp
1st name | Akira |
Middle name | |
Last name | Yamao |
Public Health Research Foundation
Comprehensive Support Project for Clinical Research
169-0051
Nishiwaseda1-1-7, Shinjyuku-ku Tokyo, 169 -0051 Japan
03-5287-2636
http://www.csp.or.jp/
cspor-office@csp.or.jp
SELECT BC-CONFIRM executive committee
Public Health Research Foundation
Non profit foundation
Japan
National Kyusyu Cancer Center
3-1-1, Notame, Minami-ku, Fukuoka-shi, Fukuoka 811-1395 Japan
092-541-3231
jutaku@nk-cc.go.jp
NO
2016 | Year | 02 | Month | 19 | Day |
Unpublished
Completed
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 06 | Month | 14 | Day |
2011 | Year | 06 | Month | 27 | Day |
2013 | Year | 12 | Month | 24 | Day |
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
2016 | Year | 02 | Month | 19 | Day |
2023 | Year | 02 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024338
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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