UMIN-CTR Clinical Trial

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
Email	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
Email	knakajo@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051559