UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053614 |
|---|---|
| Receipt number | R000061174 |
| Scientific Title | The frequency and prognosis of cachexia in fibrotic interstitial lung disease using diagnostic criteria for cachexia for Asians: A prospective observational study. |
| Date of disclosure of the study information | 2024/02/14 |
| Last modified on | 2024/02/13 15:14:52 |
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Basic information
Public title
The frequency and prognosis of cachexia in interstitial lung disease: A prospective observational study.
Acronym
Study of cachexia in interstitial lung disease.
Scientific Title
The frequency and prognosis of cachexia in fibrotic interstitial lung disease using diagnostic criteria for cachexia for Asians: A prospective observational study.
Scientific Title:Acronym
The frequency and prognosis of cachexia in fibrotic interstitial lung disease: A prospective observational study.
Region
| Japan |
Condition
Condition
Fibrotic interstitial lung diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fibrotic interstitial lung disease (fILD), which causes fibrosis of the lungs, is represented by idiopathic pulmonary fibrosis (IPF), an intractable disease for which no fundamental treatment exists other than lung transplantation, even with the advent of antifibrotic agents. Since weight loss is known to be a poor prognostic factor in IPF, early detection of cachexia and intervention may improve the prognosis of fILD patients.
In September 2023, the Asian Working Group for Cachexia published cachexia diagnostic criteria for Asians. This will play an important role in diagnosing cachexia associated with various chronic diseases in Japan, since until now only diagnostic criteria for cachexia associated with malignant tumors and cachexia involving Westerners have existed. In light of these diagnostic criteria, we will investigate the frequency and prognosis of cachexia in fILD patients in Japan.
Basic objectives2
Others
Basic objectives -Others
The percentage of patients diagnosed with cachexia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentage of patients diagnosed with cachexia
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Japanese patients 18 years of age or older at the time of consent
2) Patients diagnosed with interstitial lung disease who have at least one of the following findings on HRCT: honey comb change, traction bronchiectasis, or reticulopapillary shadows.
3) Patients who have been fully informed of the study and who have given their free and voluntary written consent based on their full understanding of the study.
Key exclusion criteria
1) Patients for whom respiratory function tests cannot be performed
2) Patients with advanced cancer comorbidities
3) Patients on dose adjustment of corticosteroids
4) Patients who are judged by the principal investigator or subinvestigator to be unsuitable for the safe conduct of this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Suzuki |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan
TEL
043-222-7171
suzutaku@chiba-u.jp
Public contact
Name of contact person
| 1st name | Ryutaro |
| Middle name | |
| Last name | Hirama |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan
TEL
043-222-7171
Homepage URL
ryu.154038@gmail.com
Sponsor or person
Institute
Chiba 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
Chiba University Hospital Observational Research Ethics Review Board
Address
1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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 | 02 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collect information on the following patients.
Patient background
Grip strength
King's Brief Interstitial Lung Disease (K-BILD)
Council on Nutrition Appetite Questionnaire into Japanese (CNAQ-J)
Blood tests (Hb, Alb, CRP, LDH, KL-6, SP-D)
High Resolution Computed Tomography
Precision respiratory function test
Repeated saliva swallow test
After enrollment, the following information will be collected periodically during the observation period.
Changes in respiratory symptoms
Number of hospitalizations
Number of acute exacerbations of interstitial lung disease
All-cause mortality
Changes in body weight
Changes in respiratory function
High Resolution Computed Tomography
Management information
Registered date
| 2024 | Year | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061174
