UMIN-CTR Clinical Trial

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
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	2020 Year 01 Month 28 Day

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