UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046882 |
|---|---|
| Receipt number | R000053495 |
| Scientific Title | A Prospective Study of Esophageal Reflux Factors in Barrett's Esophageal Cancer |
| Date of disclosure of the study information | 2022/02/13 |
| Last modified on | 2024/08/13 15:57:10 |
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Basic information
Public title
A Prospective Study of Esophageal Reflux Factors in Barrett's Esophageal Cancer
Acronym
A Prospective Study of Esophageal Reflux Factors in Barrett's Esophageal Cancer
Scientific Title
A Prospective Study of Esophageal Reflux Factors in Barrett's Esophageal Cancer
Scientific Title:Acronym
A Prospective Study of Esophageal Reflux Factors in Barrett's Esophageal Cancer
Region
| Japan |
Condition
Condition
Cases of Barrett's esophagus cancer and a case of Barrett's esophagus with GERD symptoms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the status of reflux in the esophagus, mainly gastric acid, in Barrett's esophageal cancer and Barrett's esophagus cases.
Basic objectives2
Others
Basic objectives -Others
Elucidation of the pathogenesis of a disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Esophageal reflux factors in 24-hour pH impedance monitoring
Key secondary outcomes
Esophageal motility dysfunction associated with intraesophageal reflux factors
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with Barrett's esophageal adenocarcinoma cases and patients with Barrett's esophagus who have symptoms of gastroesophageal reflux disease and are eligible for testing as gastroesophageal reflux disease under the general medical care category.
Key exclusion criteria
(1) Postoperative esophageal or gastric patients (2) Patients who have undergone esophageal radiotherapy in the past (3) Patients who have expressed their refusal to participate in the study (4) Patients who are judged by the physician in charge to be undesirable subjects for this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Koike |
Organization
Tohoku University
Division name
Department of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
0227177171
masahiro.saito.d7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University
Division name
Department of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
0227177171
Homepage URL
masahiro.saito.d7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee, Tohoku University School of Medicine
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
Tel
0227184105
med-kenkyo@grp.tohoku.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
| 2022 | Year | 02 | 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
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study that collected data from cases who underwent 24-hour pH monitoring and esophageal manometry (HRIM) within the scope of general clinical practice.
Subjects included cases with Barrett's esophageal cancer and cases of Barrett's esophagus accompanied by GERD symptoms who underwent 24-hour pH monitoring.
Management information
Registered date
| 2022 | Year | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053495
