UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007750 |
|---|---|
| Receipt number | 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 15:30:29 |
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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
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
nomura-hitomi@koshin-chem.co.jp
Sponsor or person
Institute
Koshin Chemical Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009126
