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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009998
Receipt No. R000011706
Scientific Title Gene expression analaysis of the lateral spreading tumor
Date of disclosure of the study information 2013/02/08
Last modified on 2015/08/08

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Basic information
Public title Gene expression analaysis of the lateral spreading tumor
Acronym Gene expression analaysis of the lateral spreading tumor
Scientific Title Gene expression analaysis of the lateral spreading tumor
Scientific Title:Acronym Gene expression analaysis of the lateral spreading tumor
Region
Japan

Condition
Condition colorectal tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Decision of the therapeutic strategy and pridicting the prognosis of the LST by comparison of gene expression in LST with in colorectal tumor except LST.
Basic objectives2 Others
Basic objectives -Others Gene expression analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gene expression of targeted genes
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 Patients with colorectal tumor
Key exclusion criteria Patients evaluated incompetent by doctors in attendance
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Arai
Organization Chiba University
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba City
TEL 043-222-7171
Email araim-cib@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Arai
Organization Chiba University
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba City, JAPAN
TEL 043-226-2083
Homepage URL
Email araim-cib@umin.ac.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2013 Year 02 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/26048755
Number of participants that the trial has enrolled
Results
BACKGROUND:

Laterally spreading tumors (LSTs) are generally defined as lesions >10 mm in diameter, are characterized by lateral expansion along the luminal wall with a low vertical axis. In contrast to other forms of tumor, LSTs are generally considered to have a superficial growth pattern and the potential for malignancy. We focused on this morphological character of LSTs, and analyzed the gene expression profile of LSTs.
METHODS:

The expression of 168 genes in 41 colorectal tumor samples (17 LST-adenoma, 12 LST-carcinoma, 12 Ip [pedunculated type of the Paris classification)-adenoma, all of which were 10 mm or more in diameter] was analyzed by PCR array. Based on the results, we investigated the expression levels of genes up-regulated in LST-adenoma, compared to Ip-adenoma, by hierarchical and K-means clustering. To confirm the results of the array analysis, using an additional 60 samples (38 LST-adenoma, 22 Ip-adenoma), we determined the localization of the gene product by immunohistochemical staining.
RESULT:

The expression of 129 genes differed in colorectal tumors from normal mucosa by PCR array analysis. As a result of K-means clustering, the expression levels of five genes, AKT1, BCL2L1, ERBB2, MTA2 and TNFRSF25, were found to be significantly up-regulated (p < 0.05) in LST-adenoma, compared to Ip-adenoma. Immunohistochemical analysis showed that the BCL2L1 protein was significantly and meaningfully up-regulated in LST-adenoma compared to Ip-adenoma (p = 0.010). With respect to apoptosis status in LST-Adenoma, it assumes that BCL2L1 is anti-apoptotic protein, the samples such as BCL2L1 positive and TUNEL negative, or BCL2L1 negative and TUNEL positive are consistent with the assumption. 63.2 % LST-adenoma samples were consistent with the assumption.
CONCLUSIONS:

LSTs have an unusual profile of gene expression compared to other tumors and BCL2L1 might be concerned in the organization of LSTs.
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 Completed
Date of protocol fixation
2012 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 01 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 Gene expression analaysis of colon LST

Management information
Registered date
2013 Year 02 Month 08 Day
Last modified on
2015 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011706

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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