NCT03903055

Brief Summary

MDS is a group of malignant cloned blood diseases that originated from hematopoietic stem cells(HSC) 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 abnormalities(pathological hematopoiesis), the reduction of peripheral blood cells, the high risk of conversion to acute myeloid leukemia(AML), and once converted to leukemia, the treatment prognosis is very poor.The 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

2.7 years

First QC Date

April 3, 2019

Last Update Submit

April 18, 2019

Conditions

Keywords

MDSRNA-seq

Outcome Measures

Primary Outcomes (1)

  • RNA-seq

    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

Interventions

MDS groupDIAGNOSTIC_TEST

patients diagnosed as MDS with high risk,aged 18-80,men/wemen

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the population of MDS patients were from the five centers who were visiting the doctor

You may qualify if:

  • Patients who meet MDS diagnostic criteria with high risk of IPSS-R

You may not qualify if:

  • with no MDS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZJHTCM

Hangzhou, Zhejiang, 310006, China

RECRUITING

Study Officials

  • lin s yun, doctor

    zjhtcm

    STUDY CHAIR

Central Study Contacts

LIN s yun, doctor

CONTACT

shen y ying, master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 4, 2019

Study Start

May 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations