UMIN-CTR Clinical Trial

Basic information
Public title	Validation study of the prognostic and predictive value of TP53 signature for breast cancer Collateral research
Acronym	Collateral research of validation study of TP53 signature
Scientific Title	Validation study of the prognostic and predictive value of TP53 signature for breast cancer Collateral research
Scientific Title:Acronym	Collateral research of validation study of TP53 signature
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare TP53 signature status of biopsy specimens before preoperative chemotherapy and surgical specimens and to investigate the association between TP53 signature and prognosis.
Basic objectives2	Others
Basic objectives -Others	TP53 signature status after preoperative chemotherapy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	TP53 signature status after preoperative chemotherapy Overall survival Recurrence free survival
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Cases enrolled in "Validation study of the prognostic and predictive value of TP53 signature for breast cancer". Cases in which preoperative chemotherapy was administered.
Key exclusion criteria	Cases considered by the attending physician to be unsuitable for enrollment in this study
Target sample size	107

Research contact person
Name of lead principal investigator	1st name Chikashi Middle name Last name Ishioka
Organization	Graduate School of Medicine, Tohoku University
Division name	Department of Clinical Oncology
Zip code	981-8575
Address	4-1, Seiryo-machi, Aobaku, Sendai, Miyagi, Japan
TEL	022-717-8543
Email	chikashi@tohoku.ac.jp

Public contact
Name of contact person	1st name Shin Middle name Last name Takahashi
Organization	Tohoku University Hospital
Division name	Department of Medical Oncology
Zip code	981-8575
Address	4-1, Seiryo-machi, Aobaku, Sendai, Miyagi, Japan
TEL	022-717-8543
Homepage URL
Email	shin.takahashi.e7@tohoku.ac.jp

Sponsor
Institute	Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committees of Tohoku University School of Medicine
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Japan.
Tel	022-717-7000
Email	med-kenkyo@grp.tohoku.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 09 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	No longer recruiting
Date of protocol fixation	2020 Year 10 Month 08 Day
Date of IRB	2020 Year 11 Month 16 Day
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To compare the TP53 signature status of biopsy specimens prior to preoperative chemotherapy and surgical specimens and to determine the association between TP53 signature status and prognosis.

Management information
Registered date	2020 Year 10 Month 08 Day
Last modified on	2021 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047996