UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034530 |
|---|---|
| Receipt number | R000039326 |
| Scientific Title | A Prospective Longitudinal Observational Study of Clinical Outcomes, Adverse Events, and Secondary Malignancies After Definitive Radiotherapy for Breast Cancer Patients |
| Date of disclosure of the study information | 2018/10/27 |
| Last modified on | 2020/01/28 16:05:07 |
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Basic information
Public title
A Prospective Longitudinal Observational Study of Clinical Outcomes, Adverse Events, and Secondary Malignancies After Definitive Radiotherapy for Breast Cancer Patients
Acronym
Longitudinal Observational Study after Definitive Radiotherapy for Breast Cancer (TOKYO Database)
Scientific Title
A Prospective Longitudinal Observational Study of Clinical Outcomes, Adverse Events, and Secondary Malignancies After Definitive Radiotherapy for Breast Cancer Patients
Scientific Title:Acronym
Longitudinal Observational Study after Definitive Radiotherapy for Breast Cancer (TOKYO Database)
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Rigorous long-term observation is critical in elucidating real-world clinical outcomes, adverse events, and secondary malignancies in patients with breast cancer who underwent definitive radiotherapy. This is a multicenter prospective observational study in center of Tokyo. The aim of our study is to investigate long-term outcomes including survival, recurrence, and any other relevant clinical data.
Basic objectives2
Others
Basic objectives -Others
Detailed super-long-term (life-long) observational study
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Survival data (Breast cancer specific death/Death from any cause)
Recurrence data (Loco-regional relapse/Distant metastasis)
Key secondary outcomes
Contralateral breast cancer (Synchronous/Metachronous breast cancer)
Secondary malignancies (non-breast malignant disease)
Adverse events (treatment-related/non-treatment-related)
Any other clinically meaningful events
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
All patients with invasive carcinoma/ductal carcinoma in situ/lobular carcinoma in situ of the breast whose primary therapy includes definitive radiation therapy in participating institutions
Key exclusion criteria
Patients with metastasis at diagnosis
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Kenshiro |
| Middle name | |
| Last name | Shiraishi |
Organization
The University of Tokyo Hospital
Division name
Department of Radiology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
kshiraishi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kenshiro |
| Middle name | |
| Last name | Shiraishi |
Organization
The University of Tokyo Hospital
Division name
Department of Radiology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
kshiraishi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
MITSUI Memorial Hospital
RIKEN (Medical Sciences Innovation Hub Program)
Tokyo University of Science
Name of secondary funder(s)
St. Luke's International University
Public Interest Foundation Japan Cancer Society
IRB Contact (For public release)
Organization
Research Ethics Committee at The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
MEC2017 3B-C65
Org. issuing International ID_1
MITSUI Memorial Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 27 | 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
4000
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
No longer recruiting
Date of protocol fixation
| 1978 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 1978 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Life-long observational study based on real-world cohort of all patients whose primary therapy includes definitive radiation therapy in participating institutions
TOKYO Database:
TOkyo daigaku (the university of tokyo) and mitsui Kinen (memorial) bYOin (hospital)
This big data is expected to provide real-world outcome-based evidence that is novel and useful in shared decision making and updating clinical practice guideline
Management information
Registered date
| 2018 | Year | 10 | Month | 16 | Day |
Last modified on
| 2020 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039326
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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