UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021191 |
|---|---|
| Receipt number | R000024437 |
| Scientific Title | Prediction of outcomes and response to treatments with an ultrasensitive method for assessing intratumor epigenetic heterogeneity in colorectal cancer |
| Date of disclosure of the study information | 2016/02/25 |
| Last modified on | 2022/03/01 16:40:55 |
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Basic information
Public title
Prediction of outcomes and response to treatments with an ultrasensitive method for assessing intratumor epigenetic heterogeneity in colorectal cancer
Acronym
An ultrasensitive method for assessing intratumor epigenetic heterogeneity in colorectal cancer
Scientific Title
Prediction of outcomes and response to treatments with an ultrasensitive method for assessing intratumor epigenetic heterogeneity in colorectal cancer
Scientific Title:Acronym
An ultrasensitive method for assessing intratumor epigenetic heterogeneity in colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine the clinical significance of the detection of epigenetic heterogeneity in primary tumor and plasma from colorectal cancer patients with Methylation-sensitive high resolution melt(MS-HRM).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The detection rates of epigenetic heterogeneity in primary tumor and plasma from colorectal cancer patients with Methylation-sensitive high resolution melt(MS-HRM).
Key secondary outcomes
1.To investigate the diffenrences in the detection rates between quantitative methylation specific PCR (qMSP) and MS-HRM
2.To investigate the correlations between epigenetic heterogeneity and gene expression in primary tumor from colorectal cancer patients
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients are more than 20 and less than 80 years old
2.Patients without synchronous or metachronous multiple cancers
3.Eastern Cooperative Oncology Group performance status of 0, 1, or 2
4.Patients without severe complications (heart disease, liver disease, renal disease, infection)
5.All patients were required to give written informed consent prior to enrolment in the study
Key exclusion criteria
1.Patients do not meet the inclusion criteria
2.Patients without histologically confirmed cancer
3.Patients whom investigators consider to be ineligible
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Sakamoto |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Coloproctological Surgery
Zip code
113-8421
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
kazusaka@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kiichi |
| Middle name | |
| Last name | Sugimoto |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Coloproctological Surgery
Zip code
113-8421
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
Homepage URL
ksugimo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Our institution
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
Juntendo University Faculty of Medicine
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
Tel
03-3813-3111
ksugimo@juntendo.ac.jp
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
| 2016 | Year | 02 | Month | 25 | 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
| 2016 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Cohort study
Patient enrollment: Patients who undergo surgery for colorectal cancer in our department from February 2016 to December 2017
Examination: Laboratory test (WBC, RBC, Plt, AST, ALT, T-Bil, Cre) as well as methylated DNA measurement
Management information
Registered date
| 2016 | Year | 02 | Month | 25 | Day |
Last modified on
| 2022 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024437
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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