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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001431
Receipt No. R000001665
Scientific Title Correlation between prognosis and expressions of Mcl-1(Myeloid cell leukemia-1) and Stat-3(signal transducers and activator of transcription-3) in patients with metastasized or recurrent gastrointestinal malignancy
Date of disclosure of the study information 2008/11/01
Last modified on 2008/10/15

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Basic information
Public title Correlation between prognosis and expressions of Mcl-1(Myeloid cell leukemia-1) and Stat-3(signal transducers and activator of transcription-3) in patients with metastasized or recurrent gastrointestinal malignancy
Acronym Correlation between prognosis and expressions of Mcl-1 and Stat-3 in patients with metastasized or recurrent gastrointestinal malignancy
Scientific Title Correlation between prognosis and expressions of Mcl-1(Myeloid cell leukemia-1) and Stat-3(signal transducers and activator of transcription-3) in patients with metastasized or recurrent gastrointestinal malignancy
Scientific Title:Acronym Correlation between prognosis and expressions of Mcl-1 and Stat-3 in patients with metastasized or recurrent gastrointestinal malignancy
Region
Japan

Condition
Condition Unresectable and recurrent gastric or colorectal carcinoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the relationships between Mcl-1 and Stat3 expressions of the paraffin embedded tissue and efficacy of chemotherapy in patients with unresectable or recurrent gastric and colorectal carcinoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Relationships between explession levels of apoptosis related proteins ( Mcl-1, Phospho-Stat3, Bcl-2, Bcl-xl, Bcl-xs, cIAP, cFLIP) and efficacy of chemotherapy.
Key secondary outcomes Expression level of apoptosis related protein and background of patients, pathological characters, location and types of cancers.

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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients with unresectable and recurrent gastric or colorectal carcinoma who had agreed to recieve chemotherapy at Keio University Hospital.
Key exclusion criteria Patient who is not willing to join the study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Higuchi, MD, PhD.
Organization Keio University School of Medicine, Internal Medicine
Division name Department of gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku Tokyo 160-8582
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motoko Izumiya, MD
Organization Keio University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku Tokyo 160-8582
TEL 03-3353-1211
Homepage URL
Email

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2008 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2008 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
2014 Year 03 Month 01 Day
Date trial data considered complete
2014 Year 04 Month 01 Day
Date analysis concluded
2014 Year 04 Month 01 Day

Other
Other related information All the recorded patients will be followed until the date of trial expiratoin. Otherwise the case will be treated as a withdrawal.

Management information
Registered date
2008 Year 10 Month 15 Day
Last modified on
2008 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001665

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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