UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057661 |
|---|---|
| Receipt number | R000065837 |
| Scientific Title | Multicenter observational study of oxygen saturation imaging endoscopy for treatment selection based on chemoradiotherapy sensitivity and prognostic prediction of resectable locally advanced head and neck cancer |
| Date of disclosure of the study information | 2025/04/28 |
| Last modified on | 2025/12/11 21:59:49 |
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Basic information
Public title
Using Endoscopic Oxygen Saturation Imaging to Predict the Efficacy and Prognosis of Radiotherapy for Head and Neck Cancer
Acronym
Oxygen Saturation Imaging Endoscopy Study for Head and Neck Cancer
Scientific Title
Multicenter observational study of oxygen saturation imaging endoscopy for treatment selection based on chemoradiotherapy sensitivity and prognostic prediction of resectable locally advanced head and neck cancer
Scientific Title:Acronym
Multicenter Observational Study of Head and Neck Cancer with Oxygen Saturation Imaging Endoscopy
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Oto-rhino-laryngology | Radiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
OSI (Oxygen Saturation endscopic Imaging) is used to predict the prognosis of surgical treatment and sensitivity to chemoradiotherapy for resectable locally advanced head and neck cancer, and its potential as a biomarker for treatment selection is investigated. The study will examine its potential as a biomarker for treatment selection. In addition, immunological analysis of live specimens will be performed to evaluate biological corroboration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between tumor oxygen saturation and percentage of complete response
Key secondary outcomes
Association between tumor oxygen saturation and gene expression profiles
Association between tumor oxygen saturation and protein expression profiles
Association between tumor oxygen saturation and local progression-free survival
Tumor oxygen saturation in relation to overall survival
Tumor oxygen saturation in relation to progression-free survival
Association between tumor oxygen saturation and sensitivity
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with cancers of the mid-pharynx, hypopharynx, or larynx undergoing radical treatment at the National Cancer Center Hospital East and participating institutions between the date of study approval and March 31, 2026
2) Patients diagnosed as resectable cT3 or higher by imaging tests (CT, MRI) or endoscopy
3) Patients whose tumor oxygen saturation can be measured by oxygen saturation imaging endoscopy
4) Patients who are at least 18 years of age at the time consent is obtained
5) Patients whose written consent has been obtained from the patient
Key exclusion criteria
Patients deemed inappropriate by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Matsuura |
Organization
National Cancer Center Hospital East
Division name
Department of Head and Neck Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, 277-8577 Japan
TEL
04-7133-1111
kmatsuur@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Okano |
Organization
National Cancer Center Hospital East
Division name
Department of Head and Neck Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, 277-8577 Japan
TEL
04-7133-1111
Homepage URL
wokano@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
The Uehara Memorial Foundation
UJIFILM
IRB Contact (For public release)
Organization
National Cancer Center
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, 277-8577 Japan
Tel
04-7133-1111
irst@ml.res.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
国立がん研究センター（東京都）、静岡県立がんセンター（静岡県）、埼玉県立がんセンター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 28 | 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 | 11 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Multicenter prospective cohort study
Method of recruitment of subjects: All subjects who meet the following criteria
1) Patients with cancers of the mid-pharynx, hypopharynx, or larynx undergoing radical treatment at the National Cancer Center Hospital East and participating institutions between November 8, 2023 and March 31, 2026
2) Patients diagnosed with resectable cT3 or higher by imaging tests (CT, MRI) and endoscopy
3) Patients whose tumor oxygen saturation can be measured by oxygen saturation imaging endoscopy
4) Patients who are 18 years of age or older at the time consent is obtained
5) Patients whose written consent has been obtained from the patient
Items to be measured
Oxygen saturation imaging images of the tumor site during radiotherapy (at 40 Gy) for radiotherapy cases, and 6 months after the end of treatment.
Age, gender, medical history, life history, family history, medical history, treatment history, blood test findings, endoscopy findings, imaging findings, histopathology findings
Approximately 3-4 tumor tissue specimens were collected by endoscopic biopsy at the time of duplicate cancer screening.
Management information
Registered date
| 2025 | Year | 04 | Month | 20 | Day |
Last modified on
| 2025 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065837
