UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045444 |
|---|---|
| Receipt number | R000051559 |
| Scientific Title | An exploratory study on the usefulness of endoscopic ultrasound in diagnosing the depth of pharyngeal cancer. |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2021/09/10 13:12:57 |
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Basic information
Public title
An exploratory study on the usefulness of endoscopic ultrasound in diagnosing the depth of pharyngeal cancer.
Acronym
An exploratory study on the usefulness of endoscopic ultrasound in diagnosing the depth of pharyngeal cancer.
Scientific Title
An exploratory study on the usefulness of endoscopic ultrasound in diagnosing the depth of pharyngeal cancer.
Scientific Title:Acronym
An exploratory study on the usefulness of endoscopic ultrasound in diagnosing the depth of pharyngeal cancer.
Region
| Japan |
Condition
Condition
Oropharyngeal and hypopharyngeal squamous cell carcinoma
Classification by specialty
| Gastroenterology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of EUS in diagnosing the depth of pharyngeal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity, and accuracy rate of EUS for diagnosing the depth of oropharyngeal and hypopharyngeal cancer invasion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
In the operating room, EUS is performed for pharyngeal cancer with an echo gel pad attached to the tip of the probe to diagnose the depth of the tumor.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed by conventional endoscopy as a depth of less than the muscularis propria.
2. No history of surgery or radiation therapy to the pharyngeal region.
3. No history of radiation therapy for esophageal cancer.
4. Have a plan to perform surgery or oral resection.
5. Obtained a consent from the patient
Key exclusion criteria
1. Patients with serious complications (lung disease, cardiac disease)
2. Being or possible pregnant
3. Patients with multiple cancers (however, lesions equivalent to intraepithelial or intramucosal cancers are not included in multiple cancers).
4. Having psychiatric disorder and judged unsuitable for the clinical study.
5. Patients judged unsuitable for clinical study by investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Yano |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Endoscopy
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
knakajo@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Keiichiro |
| Middle name | |
| Last name | Nakajo |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Endoscopy
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
knakajo@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
1. Cancer Medicine, Cooperative Graduate School, The Jikei University Graduate School of Medicine
2. The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel
04-7133-1111
knakajo@east.ncc.go.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
| 2021 | Year | 09 | Month | 10 | 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
| 2021 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 10 | Day |
Last modified on
| 2021 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051559
