Tokyo, Jan. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060375) titled 'A Study Using Samples from Lung Transplant Patients to Better Understand Severe Lung Diseases' on Jan. 20.
Study Type:
Observational
Primary Sponsor:
Institute - Nagoya University
Condition:
Condition - Diseases meeting the eligibility criteria for lung transplant recipients
Classification by malignancy - Others
Genomic information - YES
Objective:
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
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 Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 15 Day
Anticipated trial start date - 2026 Year 01 Month 31 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069050
Disclaimer: Curated by HT Syndication.