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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000030756 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Lung cancer | |
Classification by specialty |
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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 | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
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Eligibility | ||||
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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 |
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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 |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Gunma University |
Institute | |
Department |
Funding Source | |
Organization | Novartis Pharma K.K. |
Organization | |
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Category of Funding Organization | Profit organization |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Recruitment status | Open public recruiting | ||||||
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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. |
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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 | |
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Research case data | |
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