UMIN-CTR Clinical Trial

Basic information
Public title	Research on the construction of a regional medical care coordination system utilizing a registry in cancer treatment
Acronym	Research on the construction of a regional medical care coordination system utilizing a registry in cancer treatment
Scientific Title	Research on the construction of a regional medical care coordination system utilizing a registry in cancer treatment
Scientific Title:Acronym	Research on the construction of a regional medical care coordination system utilizing a registry in cancer treatment
Region	Japan

Condition
Condition	solid tumors
Classification by specialty	Medicine in general Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	A registry will be shared among medical institutions for solid cancer patients who plan to attend or transfer to St. Marianna University Hospital, and issues in establishing the system will be clarified. On this basis, we will continue to implement regional medical collaboration and share information with core hospitals and family doctors, aiming to improve the quality of medical care.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of items collected
Key secondary outcomes	Smoothness of sharing and collaboration of patient information using the registry (shared system) Percentage of outcome surveys Amount of entries in medical information forms Time to prepare a return form Response time

Base
Study type	Others,meta-analysis etc

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients diagnosed with solid cancer 2) Patients referred (or referred to be referred) to St. Marianna University Hospital for cancer treatment 3) Patients who have given written consent to participate in the study
Key exclusion criteria	Patients deemed inappropriate as subjects by the investigators
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Sunakawa
Organization	St. Marianna University School of Medicine
Division name	Department of Clinical Oncology
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL	0449778111
Email	y.sunakawa@marianna-u.ac.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Sunakawa
Organization	St. Marianna University School of Medicine
Division name	Department of Clinical Oncology
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL	0449778111
Homepage URL
Email	y.sunakawa@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB, St. Marianna University School of Medicine
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel	0449778111
Email	k-sienbu.mail@marianna-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 07 Month 25 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
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	Open public recruiting
Date of protocol fixation	2022 Year 01 Month 26 Day
Date of IRB	2022 Year 05 Month 13 Day
Anticipated trial start date	2022 Year 07 Month 22 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 07 Month 23 Day
Last modified on	2022 Year 07 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055204