UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001431 |
|---|---|
| Receipt number | 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 17:08:31 |
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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
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
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001665
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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