UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055521 |
|---|---|
| Receipt number | R000063424 |
| Scientific Title | Study on the Efficacy and Appropriateness of Various Treatment Methods for Primary Thyroid Lymphoma Using Tokyo Cancer Registry Data |
| Date of disclosure of the study information | 2024/09/17 |
| Last modified on | 2026/02/28 13:54:28 |
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Basic information
Public title
Study on the Efficacy and Appropriateness of Various Treatment Methods for Primary Thyroid Lymphoma Using Tokyo Cancer Registry Data
Acronym
Tokyo Thyroid Lymphoma Research (TTLR)
Scientific Title
Study on the Efficacy and Appropriateness of Various Treatment Methods for Primary Thyroid Lymphoma Using Tokyo Cancer Registry Data
Scientific Title:Acronym
Tokyo Thyroid Lymphoma Research (TTLR)
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
To evaluate the efficacy and appropriateness of different treatment methods (surgery, radiotherapy, chemotherapy) for primary thyroid lymphoma using Tokyo Cancer Registry data.
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 and 90-day mortality from diagnosis.
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 Tokyo Cancer Registry between 2012 and 2020, with ICD-O3 code C739 and excluding ICD-10 code C73.
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
300
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
None
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 | 17 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/41196039/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/41196039/
Number of participants that the trial has enrolled
401
Results
The 5-year overall survival (OS) rate was 80.5%, and the 5-year disease-specific survival (DSS) rate was 88.8%. Disease-specific mortality was concentrated within the first two years after diagnosis, particularly within the first six months. Age >=80 years and diffuse large B-cell lymphoma (DLBCL) were associated with poorer OS and DSS. No significant survival differences were observed among disease stages. Favorable outcomes were observed in selected Stage IE patients treated with surgery alone.
Results date posted
| 2026 | Year | 02 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 401 patients were included (72.1% female, 27.9% male). The median age at diagnosis was 73 years, and 27.7% were aged >=80 years. Histological subtypes were DLBCL (41.2%), MALT lymphoma (31.4%), and follicular lymphoma (6.2%). Disease stages were Stage IE (43.6%), Stage IIE (25.7%), Stage >=III (16.2%), and unknown (14.5%).
Participant flow
A total of 411 cases registered in the Tokyo Cancer Registry between 2012 and 2021 met the inclusion criteria. After excluding cases without confirmed primary thyroid lymphoma and those with zero days of survival, 401 patients were included in the final analysis.
Adverse events
NA (This was a retrospective registry-based study.)
Outcome measures
The primary outcome was overall survival (OS). Secondary outcomes included disease-specific survival (DSS), the impact of age, histological subtype, and disease stage on prognosis, and treatment outcomes among Stage IE patients receiving curative therapy.
Plan to share IPD
No.
IPD sharing Plan description
Individual participant data cannot be shared due to data use agreements and privacy protection regulations of the Tokyo Cancer Registry.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 02 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 02 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 07 | Day |
Other
Other related information
Objective:
To assess the efficacy and appropriateness of various treatment methods for primary thyroid lymphoma using Tokyo cancer registry data.
Design:
Retrospective observational study using data from the Tokyo Cancer Registry.
Setting:
This study utilizes the Tokyo Cancer Registry data. Data extraction and analysis will be conducted ensuring confidentiality and compliance with all applicable regulations.
Participants:
Patients with primary thyroid lymphoma registered in the Tokyo Cancer Registry between 2012 and 2020.
Main Outcome and Measure:
Primary outcomes will include overall survival (OS). Secondary outcomes include disease-specific survival and 90-day mortality from the date of diagnosis.
Management information
Registered date
| 2024 | Year | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063424
