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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030957
Receipt No. R000035353
Scientific Title Validation of novel diagnostic marker of lung squamous cell carcinoma by using detection of urinary protein fragment: a multicenter study
Date of disclosure of the study information 2018/03/01
Last modified on 2019/01/23

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Basic information
Public title Validation of novel diagnostic marker of lung squamous cell carcinoma by using detection of urinary protein fragment: a multicenter study
Acronym Validation of diagnostic accuracy of urinary marker for lung squamous cell carcinoma
Scientific Title Validation of novel diagnostic marker of lung squamous cell carcinoma by using detection of urinary protein fragment: a multicenter study
Scientific Title:Acronym Validation of diagnostic accuracy of urinary marker for lung squamous cell carcinoma
Region
Japan

Condition
Condition Lung squamous cell carcinoma
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to validate diagnostic accuracy of urinary protein fragment for lung squamous cell carcinoma.
Basic objectives2 Others
Basic objectives -Others Validation of diagnostic accuracy of urinary protein fragment for lung squamous cell carcinoma.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic accuracy of the urinary protein fragment for lung squamous cell carcinoma.
Key secondary outcomes 1.Comparison of diagnostic accuracy of urinary protein fragment and squamous cell carcinoma antigen (SCC) or cytokeratin 19 fragment (CYFRA) for lung squamous cell carcinoma
2. Comparison of diagnostic accuracy of urinary protein fragment and SCC or CYFRA for early-stage (Stage I) lung squamous cell carcinoma
3. Diagnostic accuracy of combination marker (urinary protein fragment and SCC, urinary protein fragment and CYFRA or urinary protein fragment, SCC and CYFRA)
4. Changes in urine level of protein fragment before and after surgery
5. Comparison of urinary level of the protein fragment between early stage (Stage 1) lung squamous cell carcinoma and advance stage (Stage 2, 3 and 4) lung squamous cell carcinoma
6. Expression level of the protein fragment or the original protein in blood and lung tissue
7. Relationship between urinary level of protein fragment and KRAS mutation and between expression level of original protein in cancer tissue and KRAS mutation
8. Relationship between the expression levels of cancer stem cell markers and urinary level of protein fragment, between the expression levels of EMT related genes in cancer tissue and urinary level of protein fragment,and between vascular invasion in cancer tissue and urinary levels of protein fragments

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 Patients with lung squamous cell carcinoma
1.Patients aged equal to or greater than 20 years-old.
2.Patients who have single lung lesion without ground glass opacity in high resolution CT (in patients who need lung cancer surgery)
3.Patients who have no findings of metastatic lesions in brain MRI or CT, thoracoabdominal CT, bone scintigraphy or FDG-PET (in patients who need lung cancer surgery)
4. Patients diagnosed lung squamous cell carcinoma by surgical pathology(WHO Classification of Tumors of The Lung, Pleura, Thymus and Heart 4th edition), cytology or histopathology
5. Patients who had a detailed briefing of the trial prior to the enrollment and voluntarily signed a consent form

Ptients with COPD
1.Patients aged equal to or greater than 40 years-old.
2. postbronchodilator FEV1/FVC (forced expiratory volume in 1s/forced vital capacity) < 0.70 assessed by spirometry and current smokers or ex-smokers
3. Patients who had a detailed briefing of the trial prior to the enrollment and voluntarily signed a consent form

Healthy controls
1.Those who are equal to or greater than 20 years-old at the time of obtaining informed consent.
2.Those who have no abnormal findings in chest X-ray, blood glucose levels, serum lipids, serum liver function, serum renal function, and urinalysis within one year of obtaining informed consent.
3.Those who do not receive any regular prescriptions.
4.Those who are never smokers.
5.Those who had a detailed briefing of the trial prior to the enrollment and voluntarily signed a consent form
Key exclusion criteria Patients with lung squamous cell carcinoma
1.Patients who received treatment for lung squamous cell carcinoma
2. Patients who have proteinuria, positive urine sugar or urine occult blood in urinalysis.
3.Patients who have renal dysfunction (Serum levels of creatinine > 2.0 mg/dl).
4.Patients who have current malignant neoplasm other than lung squamous cell carcinoma, or past history of malignant neoplasm within 5 years.
5.Patients who were diagnosed with other types of lung cancer (not lung squamous cell carcinoma)
6.Patients who have alcohol or drug dependence or who are suspected to have alcohol or drug dependence.
7.Patients who is pregnant or who is suspected to be pregnant.
8.Patients who was enrolled another clinical trial and was prescribed a study drug within one month.
9.Patients whose attending physicians consider to be inappropriate for this study.

Patients with COPD
1.Patients who have proteinuria, positive urine sugar or urine occult blood in urinalysis.
2.Patients who have current malignant neoplasm other than lung squamous cell carcinoma, or past history of malignant neoplasm within 5 years.
3.Patients who have alcohol or drug dependence or who are suspected to have alcohol or drug dependence.
4.Patients who is pregnant or who is suspected to be pregnant.
5.Patients who was enrolled another clinical trial and was prescribed a study drug within one month.
6.Patients who were clinicaly suspected lung cancer by high resolution CT within 3 months.
7.Patients who have renal dysfunction (Serum levels of creatinine > 2.0 mg/dl).
8.Patients whose attending physicians consider to be inappropriate for this study.

Healthy controls
1-5. Same criterias as COPD (1-5.)
6.Those who are current smokers or ex-smokers.
7.Those whose attending physicians consider to be inappropriate for this study.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masamitsu Nakazato
Organization University of Miyazaki
Division name Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine, Faculty of Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Japan
TEL 0985-85-2965
Email nakazato@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironobu Tsubouchi
Organization University of Miyazaki
Division name Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine, Faculty of Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Japan
TEL 0985-85-2965
Homepage URL
Email hironobu_tsubouchi@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

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
Address
Tel
Email

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
2018 Year 03 Month 01 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
2017 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information open public recruiting

Management information
Registered date
2018 Year 01 Month 23 Day
Last modified on
2019 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035353

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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