UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052387 |
|---|---|
| Receipt number | R000059787 |
| Scientific Title | an exploratory study of metabolomics in gastrointestinal tumors |
| Date of disclosure of the study information | 2023/10/03 |
| Last modified on | 2023/10/10 17:37:13 |
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Basic information
Public title
an exploratory study of metabolomics in gastrointestinal tumors
Acronym
metabolomics in GI cancers
Scientific Title
an exploratory study of metabolomics in gastrointestinal tumors
Scientific Title:Acronym
metabolomics in GI cancers
Region
| Japan |
Condition
Condition
gastrointestinal tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Gastrointestinal cancers are among the most common cancers in Japan. Although cancer screening is conducted, the screening rate is less than half due to the psychological burden of endoscopy and submitting stool samples. Although the detection sensitivity of endoscopy has increased with the use of AI and image-enhanced observation, it is still believed that a certain number of cases are missed, and it is necessary to develop methods to improve the detection rate. In order to achieve this task, we need to create a system that can efficiently detect gene transcripts and their metabolites. Also, identifying tumor-specific metabolites will lead to developing new methods to target them for treatment. As a preliminary step, we aim to search for metabolites of gastrointestinal tumors.
Basic objectives2
Others
Basic objectives -Others
pilot study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To identify differentially expressed metabolites using biopsy specimens from tumor and non-tumor areas.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 150 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with gastrointestinal cancer scheduled to undergo endoscopic treatment who have given consent to participate in this study
Key exclusion criteria
Patients whose lesion size is less than 1cm and a sufficient volume of biopsy specimen is not expected to be obtained.
Patients who are taking multiple anti-thrombotic medications and are at high risk of bleeding.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Takahashi |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-Ku, Tokyo
TEL
0338155411
takahashiyu-int@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Takahashi |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
0338155411
Homepage URL
takahashiyu-int@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
0358410818
ethics@m.u-tokyo.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
| 2023 | Year | 10 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A pilot study to identify metabolites characteristic of the cancer, using biopsy specimens from tumor and non-tumor areas for gastrointestinal cancer patients.
Specimens will be obtained from 10 patients each with esophageal, gastric, duodenal, and colorectal cancer for metabolomic analysis.
Management information
Registered date
| 2023 | Year | 10 | Month | 03 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059787
