UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study of onset predictor and drug resistor factors of central nerve system metastasis by omics methods, using cerebrospinal fluid.
Acronym	Exploratory study of onset predictor and drug resistor factors of central nerve system metastasis.
Scientific Title	Exploratory study of onset predictor and drug resistor factors of central nerve system metastasis by omics methods, using cerebrospinal fluid.
Scientific Title:Acronym	Exploratory study of onset predictor and drug resistor factors of central nerve system metastasis.
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To explore onset predictive biomarkers of central nerve system metastases.
Basic objectives2	Others
Basic objectives -Others	To reveal mechanisms of drug resistance of central nerve system metastasis, and connect to clinical application
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of biomarkers involved in affinity of tumor cells to the central nervous system.
Key secondary outcomes	Detection of factors involved in resistant to the anti-cancer agents of central nervous system 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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients with primary lung cancer as pathological (cytology or / and histology) examination. 2) Cases suspected of meningeal carcinomatosis as an image or symptom, requiring cerebrospinal fluid examination. 3) Adult cases of ages 20 and older sufficient to be able to confirm that agreement was made based on own judgment which has cognitive ability which can fully understand the contents and properties of this research
Key exclusion criteria	1) Case in which lumbar puncture and cerebrospinal fluid sampling can not be performed due to some reason (insufficient examination position, danger of cerebral hernia due to puncture, etc.)). 2) Cases judged by the attending doctor that there is a problem with the ability to consent or to understand the study plan. 3) Cases with unstable mental disorders. 4) Other cases that the attending doctor judged inappropriate, in this study
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yusuke Tsukagoshi
Organization	Gunma University Hospital
Division name	Division of Allergy and Respiratory Medicine, Integrative Center Of Internal Medicine
Zip code
Address	3-39-15, Showamachi, Maebashi city, Gunma, 371-8511, Japan
TEL	027-220-8123
Email	y.tsukagoshi@gunma-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yusuke Tsukagoshi
Organization	Gunma University Hospital
Division name	Division of Allergy and Respiratory Medicine, Integrative Center Of Internal Medicine
Zip code
Address	3-39-15, Showamachi, Maebashi city, Gunma, 371-8511, Japan
TEL	027-220-8123
Homepage URL
Email	y.tsukagoshi@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Novartis Pharma K.K.
Organization
Division
Category of Funding Organization	Profit organization
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 01 Month 20 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	2018 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date	2018 Year 01 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other

Other related information

When a lung cancer patient, who have already diagnosed pathological from the primary region, suspected to have developed meningeal carcinomatosis, we give the patient adequate information of this study. If we can obtain agreement of participate in, we divide additional 3ml for our study from the sample of cerebrospinal fluid test for diagnose meningeal carcinomatosis. That divided sample is stored in -20 degrees Celsius frozen state. When this patient is diagnosed meningeal carcinomatosis pathological, we analyse that frozen sample by omics methods, that is expressional variation gene analysis by Pac Bio RS II RNA sequence analysis and proteome analysis by mass spectrometer system. Similarly, omics analysis is carried out using the pathological specimen used at the time of pathological diagnosis of primary lung cancer. We compare their data profile to identify the genes that are specifically highly express in cancer cells of meningeal carcinomatosis, and filtering the candidate genes related CNS metastasis. With regard to the candidate genes obtained, it is verified by the large scale cancer genomics database(TCGA;https://gdc-portal.nci.nih.gov/), whether it have been actually highly expressed in the primary lung cancer with CNS metastasis.

Management information
Registered date	2018 Year 01 Month 10 Day
Last modified on	2018 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035033

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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