UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030957 |
|---|---|
| Receipt number | 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 | 2024/03/25 17:50:45 |
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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
190
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
8891692
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
8891692
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
Faculty of medicine, Univercity of Miyazaki
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
Tel
0985-85-9403
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
鳥取大学医学部附属病院呼吸器内科（鳥取県）
国立がん研究センター東病院呼吸器外科（千葉県）
大阪大学医学部附属病院呼吸器外科（大阪府）
国立病院機構宮崎東病院呼吸器内科（宮崎県）
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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data analysis in progress
Management information
Registered date
| 2018 | Year | 01 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035353
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