Ignite Creation Date:
2024-05-06 @ 1:01 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03903055
Status:
UNKNOWN
Last Update Posted:
2019-04-22
First Post:
2019-04-03
Brief Title:
Study on High-risk MDS Patients Based on RNA-seq Technology
Sponsor:
Zhejiang Provincial Hospital of TCM
Organization:
Zhejiang Provincial Hospital of TCM
Study Overview
Official Title:
Study on Improving Clinical Diagnosis Classification and Prognosis Evaluation Criteria and Precise Early Intervention Treatment of High-risk MDS Patients Based on RNA-seq Technology
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MDSRNA-seq
Brief Summary:
MDS is a group of malignant cloned blood diseases that originated from hematopoietic stem cellsHSC or CD34 progenitor cells and are still incurable Its main characteristics are the increase of primitive cells in the bone marrow accompanied by a series or multiple developmental abnormalitiespathological hematopoiesis the reduction of peripheral blood cells the high risk of conversion to acute myeloid leukemiaAML and once converted to leukemia the treatment prognosis is very poorThe bone marrow cells of MDS patients were deeply sequenced by RNA-Seq method Through differential gene expression analysis different genes related to the onset and evolution of MDS were selected and their expression levels were analyzed in different subtype MDS patients To study its significance in clinical classification prognosis assessment and early intervention treatment establish a new standard for clinical classification and prognosis evaluation based on genomic classification clarify early intervention or precise treatment schemes and significantly prolong the survival of patients Improving the quality of life
Detailed Description:
1 Study populationincluded in the standard 120 patientsaged 16 to 80 years who met the MDS diagnostic criteria in the hematology department and outpatient clinics of the four cooperative hospitals after June 2019 The diagnostic criteria refer to the WHO diagnosis of the 2016 MDS New classification The prognosis score was based on the 2012 MDS revised IPSS-R prognostic integral systemIn control group 5 patients with initial acute myeloid leukemiaAML-M2a and 5 healthy human bone marrow donation volunteers Understand the purpose of this study and sign an informed consent form
2 Clinical information collection medical history collection of selected patients Routine clinical testsincluding peripheral blood count serum ferritin VitB12 folic acid EPO levels bone marrow smears and bone marrow biopsies bone marrow flow cytometry bone marrow cytogenetics etc and follow-up and efficacy observations The clinical indicators efficacy and prognosis of the patient and the possible related genes detected were systematically analyzed
3 Research methods The bone marrow specimens collected will be extracted according to the RAN-seq operating process and the total RNA quality test and cDNA library of each sample cell will be extracted 30 Million reads per sample and Ilumina X10 PE150 will be sequenced sequencing depth 9G clear Data After the sequencing data is tested and passed the original sequencing data is pre-processed the raw data of the sequencing machine is qualitatively controlled the sequencing fragments with the sequencing connector are removed and the low-quality fuzzy N bases riboomeRNA are removed Sequencing fragments with a length of less than 20 etc Transcription of sequencing data genomic alignment of preprocessed reads and post-comparison quality control
Gene Expression Level Analysis Gene Expression Level Quantification Gene Expression Level Distribution Biological Duplication Correlation Analysis Intersample Level Clustering and PCA Analysis
Differential Expression Gene Analysis
The GO enrichment and signal pathway enrichment of different genes were analyzed and the genes specifically raised or decreased between normal samples AML samples and MDS patient samplesincluding various MDS subtypes were compared Prediction of molecular level events associated with these differential gene changessignal pathway activation or inhibition and search for differential genes that can represent disease processes
4 Data management and statistics All clinical information data are collected and entered into the computer All data are entered using the database established by the Clinical Evaluation and Analysis Center of the unit Data processing statisticians finally further fully verify and check the completeness and accuracy of data before data entry Data entry and management by the person responsible for the establishment of a dedicated database data entry and management should be entered and proofread by two data managers After completion SPSS 190 for Windows statistics software package is used for statistical processing
After the completion of clinical information data statistics and sequencing analysis results the computers in-depth learning function was used to complete the establishment of two standards and one scheme using analysis tools such as rMATS and SURVIV
2 Clinical information collection medical history collection of selected patients Routine clinical testsincluding peripheral blood count serum ferritin VitB12 folic acid EPO levels bone marrow smears and bone marrow biopsies bone marrow flow cytometry bone marrow cytogenetics etc and follow-up and efficacy observations The clinical indicators efficacy and prognosis of the patient and the possible related genes detected were systematically analyzed
3 Research methods The bone marrow specimens collected will be extracted according to the RAN-seq operating process and the total RNA quality test and cDNA library of each sample cell will be extracted 30 Million reads per sample and Ilumina X10 PE150 will be sequenced sequencing depth 9G clear Data After the sequencing data is tested and passed the original sequencing data is pre-processed the raw data of the sequencing machine is qualitatively controlled the sequencing fragments with the sequencing connector are removed and the low-quality fuzzy N bases riboomeRNA are removed Sequencing fragments with a length of less than 20 etc Transcription of sequencing data genomic alignment of preprocessed reads and post-comparison quality control
Gene Expression Level Analysis Gene Expression Level Quantification Gene Expression Level Distribution Biological Duplication Correlation Analysis Intersample Level Clustering and PCA Analysis
Differential Expression Gene Analysis
The GO enrichment and signal pathway enrichment of different genes were analyzed and the genes specifically raised or decreased between normal samples AML samples and MDS patient samplesincluding various MDS subtypes were compared Prediction of molecular level events associated with these differential gene changessignal pathway activation or inhibition and search for differential genes that can represent disease processes
4 Data management and statistics All clinical information data are collected and entered into the computer All data are entered using the database established by the Clinical Evaluation and Analysis Center of the unit Data processing statisticians finally further fully verify and check the completeness and accuracy of data before data entry Data entry and management by the person responsible for the establishment of a dedicated database data entry and management should be entered and proofread by two data managers After completion SPSS 190 for Windows statistics software package is used for statistical processing
After the completion of clinical information data statistics and sequencing analysis results the computers in-depth learning function was used to complete the establishment of two standards and one scheme using analysis tools such as rMATS and SURVIV
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None