The feasibility study for screening of early stage of lung cancer by novel urinary biomarker using protein fragments: a prospective study

The feasibility study for screening of early stage of lung cancer by novel urinary biomarker using protein fragments: a prospective study - The feasibility study for screening of early stage of lung cancer by novel urinary biomarker using protein fragments: a prospective study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037033

Enrollment

120

Registered

2019-06-12

Start date

2019-06-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pulmonary fibrosis (IPF)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHironobu Tsubouchi

University of Miyazaki Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine, Faculty of Medicine

hironobu_tsubouchi@med.miyazaki-u.ac.jp0985-85-2965

Outcome results