UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060375 |
|---|---|
| Receipt number | R000069050 |
| Scientific Title | An Analytical Study to Elucidate the Pathophysiology of Severe Progressive Chronic Lung Diseases Using Perioperative and Postoperative Samples from Lung Transplantation |
| Date of disclosure of the study information | 2026/01/20 |
| Last modified on | 2026/01/15 20:51:47 |
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Basic information
Public title
A Study Using Samples from Lung Transplant Patients to Better Understand Severe Lung Diseases
Acronym
Lung Transplant & Severe Lung Disease Study
Scientific Title
An Analytical Study to Elucidate the Pathophysiology of Severe Progressive Chronic Lung Diseases Using Perioperative and Postoperative Samples from Lung Transplantation
Scientific Title:Acronym
LANTERN Study
Region
| Japan |
Condition
Condition
Diseases meeting the eligibility criteria for lung transplant recipients
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to analyze the pathophysiology of severe progressive chronic lung diseases, including post-transplant chronic respiratory dysfunction, by integrating perioperative and postoperative samples obtained from lung transplantation with clinical data, and to clarify disease stratification and its association with clinical outcomes.
Basic objectives2
Others
Basic objectives -Others
non-interventional observational and analytical study using perioperative and postoperative lung transplantation samples and clinical data
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Longitudinal changes in lung allograft function after lung transplantation
Key secondary outcomes
Development of chronic lung allograft dysfunction (CLAD) (incidence and time to onset), overall survival and post-transplant survival, incidence and severity of primary graft dysfunction (PGD), incidence of acute rejection, development of donor-specific anti-HLA antibodies (DSA), infectious events, and exploratory associations between clinical outcomes/prognosis and sample-derived markers, including oxidative stress markers, genetic variants, and gene (RNA) and protein expression profiles.
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
Target diseases include pulmonary hypertension, idiopathic interstitial pneumonia, pulmonary emphysema, lung disorders after hematopoietic stem cell transplantation, and other diseases that meet the lung transplant recipient eligibility criteria defined by the Japanese Society of Lung and Heart-Lung Transplantation.
Patients of any age and sex.
Patients who visited the Departments of Thoracic Surgery or Respiratory Medicine at Nagoya University Hospital and underwent inpatient evaluation for lung transplantation at the same institution.
Patients who were registered for lung transplantation at Nagoya University Hospital.
Patients who underwent lung transplantation surgery at the Department of Thoracic Surgery, Nagoya University Hospital.
Patients who agreed to allow access to and research use of their clinical information.
Patients who were able to understand the content of this study and provided written informed consent.
Patients who had previously provided broad consent for the use of biological samples and clinical data under the study entitled "Exploratory Study of Novel Disease Markers Associated with Outcomes of Chronic Interstitial Lung Diseases" (Approval No. 2017-0169).
Key exclusion criteria
Patients who are unable to adequately understand the content of the study and are therefore unable to provide written informed consent.
Patients for whom it is difficult to obtain written informed consent directly from the individual.
Patients who are judged by the attending physician to be inappropriate for enrollment in this study for any reason.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toyofumi |
| Middle name | Fengshi |
| Last name | Chen-Yoshikawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Thoracic surgery
Zip code
466-8540
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2375
tyoshikawa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Ryo |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Thoracic surgery
Zip code
466-8540
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2375
Homepage URL
ryo.taiki.x3@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya 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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-741-2111
ethics@med.nagoya-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 | 01 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None at present.
Management information
Registered date
| 2026 | Year | 01 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069050
