UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058125 |
|---|---|
| Receipt number | R000066424 |
| Scientific Title | A Retrospective Observational Study Investigating the Relationship Between Thymic Carcinoma Histopathology and Postoperative Outcomes |
| Date of disclosure of the study information | 2025/06/10 |
| Last modified on | 2025/06/09 12:55:27 |
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Basic information
Public title
A Retrospective Observational Study Investigating the Relationship Between Thymic Carcinoma Histopathology and Postoperative Outcomes
Acronym
A Retrospective Observational Study Investigating the Relationship Between Thymic Carcinoma Histopathology and Postoperative Outcomes
Scientific Title
A Retrospective Observational Study Investigating the Relationship Between Thymic Carcinoma Histopathology and Postoperative Outcomes
Scientific Title:Acronym
A Retrospective Observational Study Investigating the Relationship Between Thymic Carcinoma Histopathology and Postoperative Outcomes
Region
| Japan |
Condition
Condition
Thymic carcinoma
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Thymic carcinoma is a rare malignancy with poor prognosis, and case accumulation at single institutions remains limited, resulting in a lack of sufficient research. Recent studies have suggested that tumor-infiltrating lymphocytes (TILs) and tertiary lymphoid structures (TLSs) within tumor tissues may serve as novel biomarkers in cancer immunotherapy. In addition, peripheral blood-derived markers such as the neutrophil-to-lymphocyte ratio (NLR) have attracted attention as prognostic indicators in various solid tumors. However, no study has comprehensively evaluated the relationship between these markers and clinical outcomes in thymic carcinoma.
This multicenter retrospective study aims to assess the association between TILs, TLSs, and NLR with postoperative recurrence and prognosis in thymic carcinoma. We will also analyze preoperative imaging findings, surgical procedures, and other clinical factors to identify prognostic indicators.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between tumor-infiltrating lymphocytes (TILs), tertiary lymphoid structures (TLSs), and peripheral blood-derived biomarkers (NLR, PLR, LMR, PNI, and mGPS) using surgical tissue specimens, and postoperative survival in patients with thymic carcinoma.
Key secondary outcomes
Evaluation of postoperative recurrence, cause-specific mortality, recurrence-free survival (RFS), and progression-free survival (PFS).
Analysis of overall survival and recurrence-free survival stratified by surgical procedure.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who underwent surgery for thymic carcinoma at Okayama University Hospital or collaborating institutions between January 2010 and December 2021.
2. Patients aged 20 years or older at the time of surgery.
3. Sex: male or female.
4. Inpatient or outpatient status.
Key exclusion criteria
1. Patients with insufficient remaining clinical or pathological data for analysis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Toyooka |
Organization
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name
Department of General Thoracic Surgery and Breast and Endocrinological Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama
TEL
0862357265
toyooka@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Hayashi |
Organization
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name
Department of General Thoracic Surgery and Breast and Endocrinological Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama
TEL
0862357265
Homepage URL
p27j13yv@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okayama University Thoracic Surgery Study Group (OUTSSG)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Thoracic Surgery, Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama
Tel
0862357265
p27j13yv@s.okayama-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
岡山県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | 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
106
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
| 2022 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient enrollment has been completed, and the study is currently in the data analysis phase.
Management information
Registered date
| 2025 | Year | 06 | Month | 09 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066424
