UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042128 |
|---|---|
| Receipt number | R000048073 |
| Scientific Title | Background Factors Inducing Genetic Aberrations in the Serrated Pathway Using Organoids |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2020/10/15 15:12:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Background Factors Inducing Genetic Aberrations in the Serrated Pathway Using Organoids
Acronym
Background Factors Inducing Genetic Aberrations in the Serrated Pathway Using Organoids
Scientific Title
Background Factors Inducing Genetic Aberrations in the Serrated Pathway Using Organoids
Scientific Title:Acronym
Background Factors Inducing Genetic Aberrations in the Serrated Pathway Using Organoids
Region
| Japan |
Condition
Condition
colorectal serrated lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To analyze early-stage lesions of serrated pathway-derived cancers using organoids to elucidate the triggers of colorectal cancer development, including not only genetic abnormalities but also immune responses such as gut microbiota and cytokines.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of early-stage lesions of serrated pathway-derived cancers using organoids to elucidate factors necessary for the development of colorectal cancer, including genetic abnormalities and immune responses (gut microbiota and cytokines).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with serrated colonic lesions (HP, SSL, TSA, unclassifiable, suspicious lesions included) evaluated by endoscopic diagnosis and underwent endoscopic or surgical treatment
Key exclusion criteria
(1) Lesions that cannot be classified according to the diagnostic criteria for serrated colon lesions (HP, SSL, and TSA) of the WHO classification
(2) Patients who are judged by the principal investigator to be unsuitable as subjects
In the event that the patient requests cancellation of participation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Yoshii |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8543
Address
South1 West 16 Chuo-ku, Sapporo
TEL
816612111
shinji-yoshii@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Yoshii |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8543
Address
South1 West 16 Chuo-ku, Sapporo
TEL
816612111
Homepage URL
shinji-yoshii@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University School of Medicine
Address
South1 West 16 Chuo-ku, Sapporo
Tel
816612111
shinji-yoshii@sapmed.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
| 2020 | Year | 10 | Month | 15 | 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
| 2020 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to analyze early-stage lesions of serrated pathway-derived cancers using organoids, which provide an experimental environment similar to that of real patients, and to elucidate not only genetic abnormalities but also immune responses, including intestinal microbiota and cytokines, that are necessary for the development of colorectal cancer. This study is expected to be applied to new methods of prevention and drug discovery for colorectal cancer.
Management information
Registered date
| 2020 | Year | 10 | Month | 15 | Day |
Last modified on
| 2020 | 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=R000048073
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
