UMIN-CTR Clinical Trial

Public title

Exploratory study of urinary shedding products as a novel biomarker for lung small cell carcinoma

Acronym

A urinary biomarker for lung small cell carcinoma

Scientific Title

Exploratory study of urinary shedding products as a novel biomarker for lung small cell carcinoma

Scientific Title:Acronym

A urinary biomarker for lung small cell carcinoma

Region

Japan

Condition

Small cell lung carcinoma

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Urinary protein fragments of patients with small cell lung 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 small cell lung carcinoma.

Basic objectives2

Others

Basic objectives -Others

Exploration of a novel biomarker for small cell lung carcinoma

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Detection of candidates for a diagnostic urinary biomarker of small cell lung 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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with small cell lung carcinoma
1.Patients aged equal to or greater than 20 years-old.
2.Patients diagnosed primary lung cancer.
3.Patients diagnosed small cell lung carcinoma by cytology or histology(2015 WHO Classification of Lung Tumors).
4.Previously untreated patients with small cell lung carcinoma.
5.Patients who had a detailed briefing of the trial prior to the enrollment and voluntarily signed a consent form.

Healthy controls
1.Those who age 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 prescription.
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 small cell lung carcinoma
1.Patients who has been already received any treatments for small cell lung 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 small cell lung 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 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

100

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

Name of contact person

1st name
Middle name
Last name	Nobuhiro Matsumoto

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

nobuhiro@med.miyazaki-u.ac.jp

Institute

University of Miyazaki

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

01

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2017

Year

12

Month

27

Day

Date of IRB

Anticipated trial start date

2018

Year

01

Month

22

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

No other related information

Registered date

2018

Year

01

Month

16

Day

Last modified on

2018

Year

07

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034131