UMIN-CTR Clinical Trial

Basic information
Public title	The study of surveillance in breast cancer with germline TP53 mutation
Acronym	TP53 germline mutation testing in breast cancer
Scientific Title	TP53 germline mutation testing in breast cancer
Scientific Title:Acronym	The study of surveillance in breast cancer with germline TP53 mutation
Region	Japan

Condition
Condition	Hereditary breast cancer with germline TP53 mutation
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Improvement of 5year overall survival rate in hereditary breast cancer with germline TP53 mutation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The detection of asymptomatic malignant tumours relevant to Li-Fraumeni syndrome after the treatment of breast cancer for 10 years
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Gene Device,equipment
Interventions/Control_1	Biochemical and imaging surveillance in breast cancer with TP53 germline mutation after treatment of breast cancer for 10 years
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	20 years-old <=
Age-upper limit	70 years-old >
Gender	Female
Key inclusion criteria	Breast cancer patients examined for TP53 germline testing
Key exclusion criteria	Breast cancer patients evaluated not to be appropriate for this study by the reseacher in charge
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Maeda
Organization	Faculty of medicine, University of Fukui
Division name	First Department of Surgery
Zip code	910-1193
Address	23-3, Matsuoka, Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL	0776613111
Email	maedah@u-fukui.ac.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Maeda
Organization	Faculty of medicine, University of Fukui
Division name	First Department of Surgery
Zip code	910-1193
Address	23-3, Matsuoka, Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL	0776613111
Homepage URL
Email	maedah@u-fukui.ac.jp

Sponsor
Institute	Faculty of medicine, University of Fukui
Institute
Department

Funding Source
Organization	Faculty of medicine, University of Fukui
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	University of Fukui hospital, medical research support center
Address	23-3, Matsuoka, Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
Tel	0776618529
Email	chiken@ml.u-fukui.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	2020 Year 10 Month 30 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	Preinitiation
Date of protocol fixation	2021 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2031 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 18 Day
Last modified on	2020 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048118