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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007750
Receipt No. R000009126
Scientific Title A clinical study of gene expression models for predicting chemotherapeutic response in patients with esophageal squamous cell carcinoma
Date of disclosure of the study information 2012/04/16
Last modified on 2012/04/13

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Basic information
Public title A clinical study of gene expression models for predicting chemotherapeutic response in patients with esophageal squamous cell carcinoma
Acronym Development of the prediction model for chemoresistance in esophageal cancer.
Scientific Title A clinical study of gene expression models for predicting chemotherapeutic response in patients with esophageal squamous cell carcinoma
Scientific Title:Acronym Development of the prediction model for chemoresistance in esophageal cancer.
Region
Japan

Condition
Condition Patients who are suitable for a combination chemotherapy with cisplatin and 5-FU as a first-line treatment in esophageal squamous cell carcinoma.
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To identify candidate genes responsible for chemoresistance to combination chemotherapy with 5-FU and cisplatin based on mRNA expression profile in patients with esophageal squamous cell carcinoma.
Basic objectives2 Others
Basic objectives -Others To construct a prediction model for chemoresistance in esophageal cancer.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Tumor response
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 Male and Female
Key inclusion criteria 1)Patients who are suitable for combination chemotherapy with cisplatin and 5-FU as a first-line treatment in esophageal squamous cell carcinoma.
2)Adequate organ functions; CCr (or e-GFR) >=60ml/minute; no abnormal findings or no need for treatment
3)Adult patients aged 20 years or older
4)Written informed consent obtained
Key exclusion criteria 1)Not meeting the standards of eligibility
2)Pregnant female
3)Treated with combined radiotherapy or other anticancer drugs
4)Any other inappropriate state for participating to this study estimated by doctor in charge
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisahiro Matsubara
Organization Chiba University
Division name Department of Frontier Surgery
Zip code
Address 1-8-1, Inohana, Chuoku, Chiba, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hitomi Yamagami
Organization Koshin Chemical Inc.
Division name Division of Business Development
Zip code
Address Chiba University Innovation Plaza 204, 1-8-15, Inohana, Chuoku, Chiba, Japan
TEL
Homepage URL
Email nomura-hitomi@koshin-chem.co.jp

Sponsor
Institute Koshin Chemical Inc.
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 岩手医科大学付属病院(岩手県)
熊本大学医学部附属病院(熊本県)
群馬大学医学部附属病院(群馬県)
慶應義塾大学病院(東京都)
千葉県がんセンター(千葉県)
千葉大学医学部附属病院(千葉県)
東海大学医学部付属病院(神奈川県)
東京歯科大学市川総合病院(千葉県)
独立行政法人国立病院機構九州がんセンター(福岡県)
富山大学附属病院(富山県)
和歌山県立医科大学附属病院(和歌山県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 16 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
2008 Year 08 Month 27 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To identify candidate genes responsible for chemoresistance to combination chemotherapy with 5-FU and cisplatin based on mRNA expression profile in patients with esophageal squamous cell carcinoma.

Management information
Registered date
2012 Year 04 Month 13 Day
Last modified on
2012 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009126

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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