UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062572 |
|---|---|
| Receipt number | R000071622 |
| Scientific Title | A Nationwide Survey on the Prevalence of Oligometastases in Head and Neck Cancer |
| Date of disclosure of the study information | 2026/08/13 |
| Last modified on | 2026/08/13 19:18:42 |
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Basic information
Public title
A Nationwide Survey on the Prevalence of Oligometastases in Head and Neck Cancer
Acronym
A Nationwide Survey on the Prevalence of Oligometastases in Head and Neck Cancer
Scientific Title
A Nationwide Survey on the Prevalence of Oligometastases in Head and Neck Cancer
Scientific Title:Acronym
A Nationwide Survey on the Prevalence of Oligometastases in Head and Neck Cancer
Region
| Japan |
Condition
Condition
Head and Neck Cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the current clinical practices and treatment outcomes for oligo-metastases in head and neck cancer, to compare and analyze treatment outcomes across different treatment modalities, and to conduct an exploratory evaluation of clinical factors associated with prognosis and factors influencing treatment decisions.
Basic objectives2
Others
Basic objectives -Others
Epidemiological Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Regarding oligo-metastases in head and neck cancer, we will evaluate the following: a nationwide epidemiological survey and a comparison of survival rates between surgical treatment and other treatments.
1. Frequency and clinical characteristics of oligo-metastatic cases by primary tumor site
2. Epidemiological survey of the location, number, and diagnostic methods of metastases associated with the primary tumor
3. Treatment modalities currently in use (surgical treatment, radiation therapy, drug therapy, multidisciplinary treatment, BSC (Best Supportive Care), etc.) and their treatment outcomes
4. Factors influencing treatment decisions and differences between institutions
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
| 1 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This study will collect information via questionnaires from each institution regarding patients who meet the following criteria, and will then analyze that data.
6.1. Inclusion Criteria
1. Head and neck cancer
2. The primary tumor is under control
3. Curative treatment is possible
4. No more than three metastatic lesions confined to a single organ
Patients must meet all of the above criteria (for the purposes of this study, the above criteria constitute the definition of oligometastasis).
Key exclusion criteria
Other than the selection criteria listed above.
Target sample size
2050
Research contact person
Name of lead principal investigator
| 1st name | takenori |
| Middle name | |
| Last name | ogawa |
Organization
Graduate School of Medicine, Gifu University
Division name
Otolaryngology and Head and Neck Surgery
Zip code
501-1113
Address
1-1 Yanagido, Gifu City, Gifu
TEL
058-230-6000
hasegawa.tomohiro.g3@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | tomohiro |
| Middle name | |
| Last name | hasegawa |
Organization
Gifu University
Division name
Otolaryngology and Head and Neck Surgery
Zip code
501-1113
Address
1-1 Yanagido, Gifu City, Gifu
TEL
058-230-6000
Homepage URL
hasegawa.tomohiro.g3@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
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
Gifu University
Address
1-1 Yanagido, Gifu City, Gifu
Tel
058-230-6000
hasegawa.tomohiro.g3@f.gifu-u.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
| 2026 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After obtaining approval from the ethics review committees at each participating institution, each institution acting solely as a provider of existing data will collect the following items from medical records. The data will be collected by each institution registering the information using UMIN INDICE cloud (a web based case registration system). Gifu University will manage this information online and access it to aggregate the data for analysis.
Management information
Registered date
| 2026 | Year | 08 | Month | 13 | Day |
Last modified on
| 2026 | 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=R000071622
