UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory analysis of biomarkers predicting the treatment response in esophageal squamous cell carcinoma by using biopsy samples
Title of the study (Brief title)	Analysis of biomarkers predicting the treatment response in ESCC
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To construct the effective algorism predicting the treatment response in Esophageal squamous cell carcinoma
Basic objectives2	Others
Basic objectives -Others	basic research
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification of gene profile to distinguish the response group and non-response group
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	esophageal squamous cell carcinoma patients
Key exclusion criteria	History of radiation therapy History of chemotherapy
Target sample size	100

Research contact person
Name of lead principal investigator	Manabu Muto
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Therapeutic Oncology
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL	0757514592
Email	mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Yusuke Amanuma
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Therapeutic Oncology
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL	0757513518
Homepage URL
Email	yusuke12@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Therapeutic Oncology, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Trust Accounts
Organization
Division
Category of Funding Organization	Other
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	2012 Year 09 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 08 Month 06 Day
Anticipated trial start date	2012 Year 09 Month 10 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	Unpublished
URL releasing results
Results
Other related information	We take biopsy samples of esophageal squamous cell carcinoma, and identify gene profile to distinguish the response group and the non-response group. We construct the effective algorism predicting the treatment response in esophageal squamous cell carcinoma.

Management information
Registered date	2012 Year 09 Month 06 Day
Last modified on	2018 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010109