UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055619 |
|---|---|
| Receipt number | R000063561 |
| Scientific Title | Investigation of Treatment Effectiveness and Appropriateness for Primary Thyroid Lymphoma Using Japanese National Cancer Registry Data |
| Date of disclosure of the study information | 2024/09/26 |
| Last modified on | 2025/09/29 09:11:04 |
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Basic information
Public title
Investigation of Treatment Effectiveness and Appropriateness for Primary Thyroid Lymphoma Using Japanese National Cancer Registry Data
Acronym
National Thyroid Lymphoma Research (NTLR)
Scientific Title
Investigation of Treatment Effectiveness and Appropriateness for Primary Thyroid Lymphoma Using Japanese National Cancer Registry Data
Scientific Title:Acronym
National Thyroid Lymphoma Research (NTLR)
Region
| Japan |
Condition
Condition
Primary Thyroid Lymphoma
Classification by specialty
| Endocrinology and Metabolism | Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Primary thyroid lymphoma is an extremely rare disease, and while surgery, radiotherapy, and chemotherapy are available treatment options, no standard guidelines exist to recommend a specific treatment. This study aims to investigate the effectiveness and appropriateness of various treatment options using data from the national cancer registry to provide patients with the necessary information to make informed treatment choices.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival (OS)
Key secondary outcomes
Disease-specific survival, 90-day and 180-day mortalities from diagnosis, incidence of secondary cancers, and treatment choice trends by region.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients registered in the national cancer registry between 2016 and 2020, classified under ICD-O-3 as LYMPHOID NEOPLASMS, with localization codes C73.9 (thyroid primary) or other than C73.9 and C42.1.
Key exclusion criteria
Cases with a histological diagnosis other than primary thyroid lymphoma, or cases with a survival time of 0 days from the date of diagnosis.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Saito |
Organization
Ito hospital
Division name
Department of Surgery
Zip code
160-8582
Address
4-3-6 Jinguumae, Shibuya-ku, Tokyo, Japan
TEL
+81-3-3402-7411
y-saito@ito-hospital.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Saito |
Organization
Ito hospital
Division name
Department of Surgery
Zip code
160-8582
Address
4-3-6 Jinguumae, Shibuya-ku, Tokyo, Japan
TEL
+81-3-3402-7411
Homepage URL
y-saito@ito-hospital.jp
Sponsor or person
Institute
Ito hospital
Institute
Department
Personal name
Funding Source
Organization
Ito hospital
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
Ito Hospital Institutional Review Board
Address
4-3-6 Jinguumae, Shibuya-ku, Tokyo, Japan
Tel
+81-3-3402-7411
k-sugino@ito-hospital.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
| 2024 | Year | 09 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Objective:
To assess the efficacy and appropriateness of various treatment methods (surgery, radiotherapy, and chemotherapy) for primary thyroid lymphoma using data from the national cancer registry.
Design:
A retrospective observational study using data from the national cancer registry.
Setting:
This study utilizes data from the national cancer registry. Data extraction and analysis will be conducted ensuring confidentiality and compliance with relevant regulations.
Participants:
Patients with primary thyroid lymphoma registered in the national cancer registry between 2016 and 2020.
Main Outcome and Measure:
The primary outcome will be overall survival (OS). Secondary outcomes include disease-specific survival, 90-day and 180-day mortality from the date of diagnosis, secondary cancer incidence, and treatment selection trends by region.
Management information
Registered date
| 2024 | Year | 09 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063561
