UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030756 |
|---|---|
| Receipt number | R000035033 |
| Scientific Title | Exploratory study of onset predictor and drug resistor factors of central nerve system metastasis by omics methods, using cerebrospinal fluid. |
| Date of disclosure of the study information | 2018/01/20 |
| Last modified on | 2018/01/10 21:03:11 |
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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
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
y.tsukagoshi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035033
