- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03903055
Study on High-risk MDS Patients Based on RNA-seq Technology (MDS&RNA-seq)
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
Study Overview
Detailed Description
(1) Study population(included in the standard): 120 patients(aged 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 system.In control group, 5 patients with initial acute myeloid leukemia(AML-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 tests(including 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 samples(including various MDS subtypes) were compared. Prediction of molecular level events associated with these differential gene changes(signal 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 19.0 for Windows statistics software package is used for statistical processing.
After the completion of clinical information data statistics and sequencing analysis results, the computer's "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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: LIN s yun, doctor
- Phone Number: 13588887285
- Email: lsyww@163.com
Study Contact Backup
- Name: shen y ying, master
- Phone Number: 18072946912
- Email: 413808426@qq.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310006
- Recruiting
- ZJHTCM
-
Contact:
- lin s yun, doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients who meet MDS diagnostic criteria with high risk of IPSS-R
Exclusion Criteria:
with no MDS
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RNA-seq
Time Frame: 2021-2022
|
use questionnaire to research whether the target mutation gene combination analyzed by transcription group was consistent with clinical cell morphological diagnosis and disease progression.
|
2021-2022
|
Collaborators and Investigators
Investigators
- Study Chair: lin s yun, doctor, ZJHTCM
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on MDS
-
Assiut UniversityUnknown
-
Groupe Francophone des MyelodysplasiesNovartisUnknown
-
Rigshospitalet, DenmarkRecruiting
-
GWT-TUD GmbHRecruiting
-
University Hospital TuebingenRecruiting
-
Montefiore Medical CenterRecruitingAML | MDSUnited States
-
The Second Hospital of Shandong UniversityNot yet recruiting
-
Groupe Francophone des MyelodysplasiesAstex Pharmaceuticals, Inc.Active, not recruiting
-
M.D. Anderson Cancer CenterRecruiting
-
University of FlorenceRecruiting
Clinical Trials on MDS group
-
Orlucent, IncUniversity Hospitals, Leicester; NHS Tayside; University of Dundee; NHS Greater... and other collaboratorsCompletedMelanoma | Skin Lesion | MolesUnited Kingdom
-
Orlucent, IncHadassah Medical OrganizationCompleted
-
University Of PerugiaRecruitingMDS and Allogeneic Stem Cell TransplantationItaly
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Gastro Intestinal Surgery and Liver Transplantation; The Hepato-Oncology Group...CompletedRadioembolization With Yttrium-90 Microspheres for Intermediate or Advanced Hepatocellular CarcinomaHepatocellular Carcinoma | Liver CancerItaly
-
University Hospital, BrestRecruitingMyelodysplastic Syndromes | Chromosome Abnormality | Acute Myeloid Leukemia With Multilineage Dysplasia | Myelodysplastic Syndrome With Ring Sideroblasts | Myelodysplastic Anemia | Myelodysplastic Syndrome With Isolated Del(5Q)France
-
Alberta Health Services, CalgaryCentre for Aging and Brain Health Innovation; Catalyst Healthcare Ltd.CompletedHypertension | Diabetes | Arthritis | Chronic Pain | Asthma | Medication Adherence | Anxiety Depression | Medication Compliance | Medication NonadherenceCanada
-
University of California, San FranciscoUniversity of California, Los Angeles; University of California, Davis; University... and other collaboratorsRecruitingUveitis | Infectious DiseaseUnited States
-
US Department of Veterans AffairsCompleted
-
Assiut UniversityNot yet recruitingParkinson's Disease
-
The Grant Medical College & Sir J.J. Group of HospitalsRecruitingSurgical Wound Infection | Surgical Site InfectionIndia