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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034530
Receipt No. 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 2019/04/18

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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 obsevational 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
Email 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
Email kshiraishi-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

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
Email 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
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039326

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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