UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of molecular test for breast cancer
Title of the study (Brief title)	Development of molecular test for breast cancer
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The aim of this study is to develop molecular test for prognosis or chemo sensitivity in breast cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	predictability of prognosis. predictability of chemo sensitivity
Key secondary outcomes	correlation of TP53 mutation

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	breast cancer patient concent to this study
Key exclusion criteria	none
Target sample size	500

Research contact person
Name of lead principal investigator	Shin Takahashi
Organization	Tohoku univ. hosp.
Division name	Department of Medical Oncology
Address	1-1, Seiryo-machi, Aobaku, Miyagi, Japan
TEL	022-717-8547
Email	swt@idac.tohoku.ac.jp

Public contact
Name of contact person	Shin Takahashi
Organization	Tohoku univ. hosp.
Division name	Department of Medical Oncology
Address	1-1, Seiryo-machi, Aobaku, Miyagi, Japan
TEL	022-717-8547
Homepage URL
Email	swt@idac.tohoku.ac.jp

Sponsor
Institute	Department of Medical Oncology, Tohoku univ. hosp.
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	2011 Year 03 Month 03 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2003 Year 06 Month 19 Day
Anticipated trial start date	2003 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://onlinelibrary.wiley.com/doi/10.1111/j.1349-7006.2007.00691.x/abstract
Results	Cancer Sci. 2008 Feb;99(2):324-32.
Other related information	<Object> The object of this study is to develop diagnostic biomarkers for breast cancer patients. (1) To identify expression profiles that can predict the prognosis of breast cancer patients, and to develop more convenient methods to analyze these expression profiles. (2) To develop molecular diagnostic tools to examine the status of known molecular markers (expression of hormone receptor, uPA/PAI-1, HER2/neu and c-myc, TP53 gene mutation) using expression profiles. (3) To identify difference of molecular mechanisms of invasive micropapillary carcinoma which is one of the most malignant subtype of breast cancer and invasive ductal carcinoma which is the most common subtype of breast cancer by microarray analysis. <Subject> Breast cancer patients who undergo surgery or biopsy with informed consent to this study. <Methods> This study is approved by ethics committee of Tohoku University. Recruitment of the patients starts in June, 2003. Clinicopathological information is obtained from patient records. Surgical or biopsy specimens are frozen and stored in -80 degree celsius. Total RNA and DNA are extracted from the tumor tissues, and stored in -80 degree celsius until the subsequent analysis. Total RNA is used for Microarray analysis and DNA is used for sequence analysis. Gene sets correlate to prognosis or those molecular marker status are identified by statistical analysis.

Management information
Registered date	2011 Year 03 Month 02 Day
Last modified on	2017 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005294