UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059107 |
|---|---|
| Receipt number | R000067614 |
| Scientific Title | Research Aiming to Identify Abnormal Internal Carotid Artery Course in Pharyngeal-Laryngeal Dysesthesia and Standardize Diagnostic Methods -Research on Identifying Abnormal Internal Carotid Artery Course in Pharyngeal-Laryngeal Dysesthesia and Its Clinical Significance- |
| Date of disclosure of the study information | 2025/09/17 |
| Last modified on | 2025/09/17 12:52:35 |
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Basic information
Public title
Research Aiming to Identify Abnormal Internal Carotid Artery Course in Pharyngeal-Laryngeal Dysesthesia and Standardize Diagnostic Methods
-Research on Identifying Abnormal Internal Carotid Artery Course in Pharyngeal-Laryngeal Dysesthesia and Its Clinical Significance-
Acronym
Research Aiming to Identify Abnormal Internal Carotid Artery Course in Pharyngeal-Laryngeal Dysesthesia and Standardize Diagnostic Methods
-Research on Identifying Abnormal Internal Carotid Artery Course in Pharyngeal-Laryngeal Dysesthesia and Its Clinical Significance-
Scientific Title
Research Aiming to Identify Abnormal Internal Carotid Artery Course in Pharyngeal-Laryngeal Dysesthesia and Standardize Diagnostic Methods
-Research on Identifying Abnormal Internal Carotid Artery Course in Pharyngeal-Laryngeal Dysesthesia and Its Clinical Significance-
Scientific Title:Acronym
Research Aiming to Identify Abnormal Internal Carotid Artery Course in Pharyngeal-Laryngeal Dysesthesia and Standardize Diagnostic Methods
-Research on Identifying Abnormal Internal Carotid Artery Course in Pharyngeal-Laryngeal Dysesthesia and Its Clinical Significance-
Region
| Japan |
Condition
Condition
Pharyngeal Foreign Body Sensation Syndrome, Abnormal course of the internal carotid artery
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Proposal for a diagnostic method to detect abnormal internal carotid artery changes associated with aging early on, based on pharyngeal dysesthesia symptoms, thereby preventing cerebral infarction. This proposal will enhance the diagnostic accuracy of pharyngeal dysesthesia-the sole symptom reported by patients with abnormal internal carotid artery course variations-promoting understanding of the disease concept. This will not only advance public health and longevity in Japan's aging society but also significantly reduce healthcare costs by suppressing cerebral infarction incidence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Final diagnosis of patients referred to ENT outpatient clinics for pharyngeal discomfort, including proportion of cases with Ab-ICA
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients presenting with pharyngeal dysesthesia symptoms and visiting the hospital for cause investigation (so-called pharyngeal dysesthesia syndrome)
(2) Patients aged 65 years or older
Key exclusion criteria
(1) Patients suspected of having cancer and prioritized for testing
(2) If the principal investigator or co-investigator determines that participation in this study is inappropriate
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Tsunoda |
Organization
National Hospital Organization Tokyo Medical Center
Division name
National Institute of Sensory Organ Artificial Organs & Medical Creations
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, 152-8902, Japan
TEL
0334110111
koichi.tsunoda@kankakuki.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Tsunoda |
Organization
National Hospital Organization Tokyo Medical Center
Division name
National Institute of Sensory Organ Artificial Organs & Medical Creations
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, 152-8902, Japan
TEL
0334110111
Homepage URL
koichi.tsunoda@kankakuki.jp
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center National Institute of Sensory Organ
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
National Hospital Organization Tokyo Medical Center
Address
2-5-1 Higashigaoka, Meguro-ku, 152-8902, Japan
Tel
03-3411-0111/+81-3-3411-0111
koichi.tsunoda@kankakuki.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
| 2025 | Year | 09 | Month | 17 | 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
| 2023 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Confirm the presence or absence of abnormal displacement of the internal carotid artery (Ab-ICA) during otolaryngological laryngopharyngeal examination in the seated position.
Only cases with Ab-ICA identified during the screening examination after registration will undergo an observational study with a 6-month observation period following case registration.
For cases without Ab-ICA, observation ends upon confirmation of the final diagnosis. The principal investigator at each facility will verify the diagnosis, record it on the case registration form, and complete registration.
Management information
Registered date
| 2025 | Year | 09 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067614
