UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037033 |
|---|---|
| Receipt number | R000042191 |
| Scientific Title | The feasibility study for screening of early stage of lung cancer by novel urinary biomarker using protein fragments: a prospective study |
| Date of disclosure of the study information | 2019/06/12 |
| Last modified on | 2024/06/15 18:51:46 |
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Basic information
Public title
The feasibility study for screening of early stage of lung cancer by novel urinary biomarker using protein fragments: a prospective study
Acronym
The feasibility study for screening of early stage of lung cancer by novel urinary biomarker using protein fragments: a prospective study
Scientific Title
The feasibility study for screening of early stage of lung cancer by novel urinary biomarker using protein fragments: a prospective study
Scientific Title:Acronym
The feasibility study for screening of early stage of lung cancer by novel urinary biomarker using protein fragments: a prospective study
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis (IPF)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the detectability of lung cancer of urinary protein fragment and compare the detectability of the fragment with established blood tumour markers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of detectability of lung cancer of urinary protein fragment and established blood tumour markers at the time of lung cancer diagnosis in patients with IPF
Key secondary outcomes
1)Comparison of detectability of lung adenocarcinoma of urinary protein fragment and CEA at the time of diagnosis of lung adenocarcinoma in patients with IPF
2) Comparison of detectability of lung squamous cell carcinoma of urinary protein fragment and established blood tumour markers (SCC, CYFRA) at the time of diagnosis of lung squamous cell carcinoma in patients with IPF
3)Comparison of the value of urinary protein fragments before and after diagnosis of lung cancer
4)Comparison of the value of urinary protein fragments in IPF patients with lung cancer and without lung cancer.
5)Comparison of the value of urinary protein fragments in IPF patients who experienced acute exacerbation and IPF patients without exacerbation
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 aged equal to or greater than 20 years-old.
2)Patients diagnosed as IPF based of an Official ATS/ERS/JRS/ALAT Clinical Practice Guideline.
3)Patients who had a detailed briefing of the trial prior to the enrollment and voluntarily signed a consent form
Key exclusion criteria
1)Patients who have abnormal shadow (more than or equal to 1.0 cm) clinicaly suspected lung cancer by high resolution CT.
2)Patients who have proteinuria, positive urine sugar or urine occult blood in urinalysis (more than or equal to 2+).
3)Patients who have renal dysfunction (Serum levels of creatinine > 2.0 mg/dl).
4)Patients who have alcohol or drug dependence or who are suspected to have alcohol or drug dependence.
5)Patients who is pregnant or who is suspected to be pregnant.
6)Patients who was enrolled another clinical trial and was prescribed a study drug within one month.
7)Patients whose attending physicians consider to be inappropriate for this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masamitsu |
| Middle name | |
| Last name | Nakazato |
Organization
University of Miyazaki
Division name
Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine, Faculty of Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
TEL
0985-85-2965
nakazato@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Tsubouchi |
Organization
University of Miyazaki
Division name
Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine, Faculty of Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
TEL
0985-85-2965
Homepage URL
hironobu_tsubouchi@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-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
宮崎大学医学部附属病院
長崎大学病院
産業医科大学病院
鳥取大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
107
Results
The urine of 107 patients with idiopathic pulmonary fibrosis, who were at high risk of developing lung cancer, was prospectively collected (for two years) and the trend of urinary AMBP fragments in cases of lung cancer development was investigated. The results showed that AMBP fragment levels increased by 70% in patients who developed lung adenocarcinoma compared with those before the onset of the disease. These results suggest that AMBP fragments may be able to determine the disease status of lung cancer.
Results date posted
| 2024 | Year | 06 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with idiopathic pulmonary fibrosis attending or being admitted to the centres participating in the study will be included.
Inclusion criteria.
(1) Patients aged 20 years or older at the time of obtaining consent.
(ii) Patients with a clinical diagnosis of idiopathic pulmonary fibrosis (patients who meet the criteria for UIP or probable UIP in the HRCT pattern in the ATS/ERS/JRS/ALAT International Diagnostic Guidelines)
(iii) Patients who have given a full explanation of their participation in the study, and who have given their free written consent based on a full understanding of the study.
Participant flow
prospective observational study
Adverse events
No adverse effect
Outcome measures
Primary outcome.
Comparison of diagnostic accuracy of urinary protein fragments and serum tumour markers in patients with idiopathic pulmonary fibrosis who developed lung cancer at diagnosis
Secondary outcomes
1) Comparison of diagnostic accuracy of urinary protein fragments and serum tumour markers (CEA) in patients with idiopathic pulmonary fibrosis who developed lung adenocarcinoma (at diagnosis of lung adenocarcinoma)
2) Comparison of diagnostic accuracy of urinary protein fragments and serum tumour markers (SCC, CYFRA) in patients with idiopathic pulmonary fibrosis who developed lung squamous cell carcinoma (at diagnosis of lung squamous cell carcinoma)
3) Comparison of urinary protein fragment levels before the development of lung cancer (at the time of the most recent specimen collection from the diagnosis of lung cancer, 6 months before the time of the most recent specimen collection, or at the time of registration) and at the time of diagnosis
4) Differences in urinary protein fragment levels between the groups that developed lung cancer and those that did not (at the time of lung cancer diagnosis in the lung cancer group and at the time of registration in the non-development group)
5) Differences in urinary protein fragment levels in the group with exacerbation of idiopathic pulmonary fibrosis during the observation period and in the group without exacerbation (at enrolment).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
No other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 12 | Day |
Last modified on
| 2024 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042191
