UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046901 |
|---|---|
| Receipt number | R000053191 |
| Scientific Title | Utility of thyroid transcription factor-1 as a predictor of immune checkpoint inhibition plus chemotherapy in advanced lung adenocarcinoma. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2025/02/26 23:13:26 |
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Basic information
Public title
Utility of thyroid transcription factor-1 as a predictor of immune checkpoint inhibition plus chemotherapy in advanced lung adenocarcinoma.
Acronym
TTF-1 and immunochemotherapy in advanced lung adenocarcinoma
Scientific Title
Utility of thyroid transcription factor-1 as a predictor of immune checkpoint inhibition plus chemotherapy in advanced lung adenocarcinoma.
Scientific Title:Acronym
TTF-1 and immunochemotherapy in advanced lung adenocarcinoma
Region
| Japan |
Condition
Condition
Advanced Lung Adenocarcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether TTF-1 is a predictive marker of patients treated with immune checkpoint inhibitors plus chemotherapy for advanced lung adenocarcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare progression-free survival (PFS) in patients with TTF-1 positive and negative tumors
Key secondary outcomes
To analyze objective response rate (ORR) PFS and overall survival(OS). To compare ORR and OS in patients with TTF-1 positive and negative tumors. To compare ORR, PFS and OS in patients with TTF-1 positive and negative tumors of Hematoxylin-Eosin Stain-diagnosed lung adenocarcinoma and in patients with TTF-1-diagnosed non-small cell lung cancer (NSCLC) favor adenocarcinoma. To compare ORR, PFS and OS in patients with TTF-1 positive and negative tumors for each chemotherapy regimen. To compare ORR, PFS and OS in patients for each PD-L1 expression. To compare ORR, PFS and OS in patients with TTF-1 positive and negative tumors for each PD-L1 expression. To compare TTF-1 positivity rates by histopathology and compare ORR, PFS and OS in patients with TTF-1 positive and negative tumors.
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 with histologically diagnosed lung adenocarcinoma
(2) Patients who received immune checkpoint inhibitors plus chemotherapy for advanced recurrent lung adenocarcinoma
(3) Patients whose information can be obtained from the medical record
(4) more than 20 years old
Key exclusion criteria
(1) Patients who have requested not to participate in this study
(2) Patients who are judged ineligible by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Tachihara |
Organization
Kobe University Graduate School of Medicine
Division name
division of respiratory medicine, department of Internal medicine,
Zip code
650-0017
Address
Kobe, Hyogo, Japan. 7-5-1, Kusunoki-Cho, Chuo-Ku, Kobe-city, Hyogo
TEL
078-382-5660
mt0318@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Yamada |
Organization
Kobe University Graduate School of Medicine
Division name
division of respiratory medicine, department of Internal medicine,
Zip code
650-0017
Address
Kobe, Hyogo, Japan. 7-5-1, Kusunoki-Cho, Chuo-Ku, Kobe-city, Hyogo
TEL
0783825660
Homepage URL
jyamada@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
Funding Source
Organization
Kobe 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
Secretariat of the Medical Ethics Review Committee (Observational Research)
Address
Kobe, Hyogo, Japan. 7-5-1, Kusunoki-Cho, Chuo-Ku, Kobe-city, Hyogo
Tel
0783825111
kansatsu@med.kobe-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
神戸大学医学部附属病院（兵庫県）、兵庫県立丹波医療センター（兵庫県）、兵庫県立淡路医療センター（兵庫県）、社会医療法人製鉄記念広畑病院（兵庫県）、社会医療法人愛仁会明石医療センター（兵庫県）、社会医療法人愛仁会高槻病院（大阪府）、公益財団法人甲南会甲南医療センター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | 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
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate histology, TTF-1, immunochemotherapy regimen, response rate, overall survival, and progression-free survival in patients who received at least one course of immunochemotherapy for advanced lung adenocarcinoma between January 1, 2019 and August 31, 2021.
Management information
Registered date
| 2022 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053191
