UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048038 |
|---|---|
| Receipt number | R000054728 |
| Scientific Title | A prospective crossover randomized controlled trial evaluating the efficacy of texture and color enhancement imaging (TXI) for identification of colorectal neoplasms |
| Date of disclosure of the study information | 2022/06/13 |
| Last modified on | 2023/12/14 12:49:02 |
* 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
A prospective crossover randomized controlled trial evaluating the efficacy of texture and color enhancement imaging (TXI) for identification of colorectal neoplasms
Acronym
Efficacy of TXI for identification of colorectal neoplasms
Scientific Title
A prospective crossover randomized controlled trial evaluating the efficacy of texture and color enhancement imaging (TXI) for identification of colorectal neoplasms
Scientific Title:Acronym
TXI study
Region
| Japan |
Condition
Condition
colorectal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of texture and color enhancement imaging (TXI) for identification of colorectal neoplasms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adenoma (polyp) detection rate
Key secondary outcomes
colorectal neoplasms detected per patient
% Increase in detection rate
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 over 20 years old undergoing colonoscopy
Key exclusion criteria
1. Patients in disagreement with informed consent.
2. Patients with inadequate bowel preparation (BBPS: score0 or 1).
3. Patients with previous right-sided colorectal resection.
4. Patients with inflammatory bowel disease.
5. Patients with familial adenomatous polyposis.
6. Patients with Peytz-Jeghers syndrome.
7. Patients with hereditary polyposis syndromes.
8. Other, patients deemed by the treating physician to be ineligible for inclusion in the study.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Sakai |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Department of Gastroenterology
Zip code
2478581
Address
132 Katsuracho, Sakae-ku, Yokohama, Kanagawa
TEL
045-891-2171
eiji-not_found@goo.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Sakai |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Department of Gastroenterology
Zip code
2478581
Address
132 Katsuracho, Sakae-ku, Yokohama, Kanagawa
TEL
045-891-2171
Homepage URL
eiji-not_found@goo.jp
Sponsor or person
Institute
Yokohama Sakae Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama Sakae Kyosai Hospital
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
Yokohama Sakae Kyosai Hospital
Address
132 Katsuracho, Sakae-ku, Yokohama, Kanagawa
Tel
0458912171
eiji-not_found@goo.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
| 2022 | Year | 06 | Month | 13 | 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
700
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054728
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
