UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030842
Receipt number R000034468
Scientific Title Exploratory study of urinary shedding products as a novel biomarker for early stage lung squamous cell carcinoma
Date of disclosure of the study information 2018/01/18
Last modified on 2023/05/18 13:47:35

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Basic information

Public title

Exploratory study of urinary shedding products as a novel biomarker for early stage lung squamous cell carcinoma

Acronym

A urinary biomarker for early stage lung squamous cell carcinoma

Scientific Title

Exploratory study of urinary shedding products as a novel biomarker for early stage lung squamous cell carcinoma

Scientific Title:Acronym

A urinary biomarker for early stage lung squamous cell carcinoma

Region

Japan


Condition

Condition

Squamous cell carcinoma of the lung

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Urinary protein fragments of patients with lung squamous cell carcinoma are analyzed by mass spectrometry. The results of the exhaustive analysis are compared to those of healthy volunteers. The objective of this study is to identify protein fragments in urine, which are useful for detecting early stage lung squamous cell carcinoma.

Basic objectives2

Others

Basic objectives -Others

Exploration of a novel biomarker for lung squamous cell carcinoma

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Detection of candidates for a diagnostic urinary biomarker, whose sensitivity is higher than that of any other existing biomarker, of lung squamous cell carcinoma

Key secondary outcomes

1.Sensitivity, specificity, positive likelihood ratio and negative likelihood ratio of the detected biomarkers.
2.Confirmation of the protein fragments, pre-fragmented proteins and cleaving enzymes in tissue and blood samples.
3.Relationship between the detected biomarkers and prognosis.
4.Relationship between the detected biomarkers and presence of metastasis.


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 diagnosed lung squamous cell carcinoma by surgical pathology(WHO Classification of Tumors of The Lung, Pleura, Thymus and Heart 4th edition).
3.Patients diagnosed pathological stage I lung squamous cell carcinoma(UICC-TNM Classification 8th edition).
4.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 have proteinuria, positive urine sugar or urine occult blood in urinalysis.
2.Patients who have renal dysfunction (Serum levels of creatinine > 2.0 mg/dl).
3.Patients who do not undergo a curative surgery.
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 have alcohol or drug dependence or who are suspected to have alcohol or drug dependence.
6.Patients who is pregnant or who is suspected to be pregnant.
7.Patients who was enrolled another clinical trial and was prescribed a study drug within one month.
8.Patients who was not collected samples before curative surgery.
9.Patients whose attending physicians consider to be inappropriate for this study.

Healthy controls
1.Those who have proteinuria, positive urine sugar or urine occult blood in urinalysis.
2.Those who have past history of malignant neoplasm within 5 years.
3.Those who have alcohol or drug dependence or who are suspected to have alcohol or drug dependence.
4.Those who are pregnant or who are suspected to be pregnant.
5.Those who were enrolled another clinical trial and were prescribed a study drug within one month.
6.Those who are current smokers or ex-smokers.
7.Those whose attending physicians consider to be inappropriate for this study.

Target sample size

80


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

Email

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


Email

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 Hospital, Clinical Research Support Center

Address

5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN

Tel

+81-985-85-2965

Email

rinken@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



Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 18 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 12 Month 18 Day

Date of IRB

2017 Year 12 Month 17 Day

Anticipated trial start date

2018 Year 01 Month 22 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 05 Month 17 Day


Other

Other related information

No other related information


Management information

Registered date

2018 Year 01 Month 16 Day

Last modified on

2023 Year 05 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034468


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name