The feasibility study for lung cancer screening by novel urinary biomarker using protein fragments: a cross-sectional study

The feasibility study for lung cancer screening by novel urinary biomarker using protein fragments: a cross-sectional study - The feasibility study for lung cancer screening by novel urinary biomarker using protein fragments: a cross-sectional study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037032

Enrollment

200

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

Lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients aged equal to or greater than 20 years-old. 2)Patients who have solitary nodular shadow (more than or equal to 1cm) or mass shadow (< 7cm) clinicaly suspected lung cancer by high resolution CT within 3 months. 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 multiple nodular shadows(more than or equal to 0.5cm) and/or multiple mass shadows clinicaly suspected tumor metastasis and/or pleural effusion by high resolution CT within 3 months. 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 diagnostic accuracy of urinary protein fragment and carcinoembryonic antigen (CEA) for lung adenocarcinoma	—

Secondary

Measure	Time frame
1) Comparison of diagnostic accuracy of urinary protein fragment and established blood tumour markers (CEA, SCC and CYFRA) for lung cancer 2) Comparison of diagnostic accuracy of urinary protein fragment and carcinoembryonic antigen (CEA) for early stage of lung adenocarcinoma (cStage I-II) 3) Comparison of diagnostic accuracy of urinary protein fragment and carcinoembryonic antigen (CEA) for late stage of lung adenocarcinoma (cStage III-IV) 4)Comparison of diagnostic accuracy of urinary protein fragment and carcinoembryonic antigen (CEA) for lung adenocarcinoma in the subjects without heavy smokers (> 10 pack-year 5) Diagnostic accuracy of combination marker (urinary protein fragments and established blood tumour markers)	—

Measure

Time frame

1) Comparison of diagnostic accuracy of urinary protein fragment and established blood tumour markers (CEA, SCC and CYFRA) for lung cancer 2) Comparison of diagnostic accuracy of urinary protein fragment and carcinoembryonic antigen (CEA) for early stage of lung adenocarcinoma (cStage I-II) 3) Comparison of diagnostic accuracy of urinary protein fragment and carcinoembryonic antigen (CEA) for late stage of lung adenocarcinoma (cStage III-IV) 4)Comparison of diagnostic accuracy of urinary protein fragment and carcinoembryonic antigen (CEA) for lung adenocarcinoma in the subjects without heavy smokers (> 10 pack-year 5) Diagnostic accuracy of combination marker (urinary protein fragments and established blood tumour markers)

—

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