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出境医 / 临床实验 / Dose-effect Relationship Between microRNAs in Peripheral Blood and Radiation Injury

Dose-effect Relationship Between microRNAs in Peripheral Blood and Radiation Injury

Study Description
Brief Summary:
Rapid and accurate assessment of radiation injury dose is the key to success in early treatment and an urgent issue to be solved in clinical medicine.Researches showed that the expression of the microRNAs in human peripheral blood had much correlation with radiation injury resulted from different dosages of radiation.In this study,acute leukemic patients who will be pretreated by whole-body radiation are taked as the object of study,and biochip technology are adopted to detect the expression levels of the microRNAs in subject peripheral blood before-and-after radiation,and different expression is tested and Bioinformatics prediction,to evaluate the correlation between radiation injury dose and expression levels of the microRNAs in human peripheral blood.

Condition or disease Intervention/treatment
Radiation Injuries, Experimental Radiation: 5 Gy or 10 Gy units of whole-body radiation

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study on Dose-effect Relationship Between Radiation Injury Dose and Expression of Associated microRNAs in Human Peripheral Blood
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : September 1, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. expression levels of the microRNAs [ Time Frame: 12 hours ]
    the expression levels of the microRNAs in human peripheral blood before radiation，12 hours after radiation and 24 hours after radiation


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date April 24, 2019
First Posted Date April 26, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date December 1, 2018
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2019) 		expression levels of the microRNAs [ Time Frame: 12 hours ]
the expression levels of the microRNAs in human peripheral blood before radiation，12 hours after radiation and 24 hours after radiation
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dose-effect Relationship Between microRNAs in Peripheral Blood and Radiation Injury
Official Title Study on Dose-effect Relationship Between Radiation Injury Dose and Expression of Associated microRNAs in Human Peripheral Blood
Brief Summary Rapid and accurate assessment of radiation injury dose is the key to success in early treatment and an urgent issue to be solved in clinical medicine.Researches showed that the expression of the microRNAs in human peripheral blood had much correlation with radiation injury resulted from different dosages of radiation.In this study,acute leukemic patients who will be pretreated by whole-body radiation are taked as the object of study,and biochip technology are adopted to detect the expression levels of the microRNAs in subject peripheral blood before-and-after radiation,and different expression is tested and Bioinformatics prediction,to evaluate the correlation between radiation injury dose and expression levels of the microRNAs in human peripheral blood.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Acute leukemic patients after chemotherapy,who will be pretreated by whole-body irradiation
Condition Radiation Injuries, Experimental
Intervention Radiation: 5 Gy or 10 Gy units of whole-body radiation
8 subjects will be received 5 Gy units of whole-body radiation or 10 Gy units of whole-body radiation.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 24, 2019) 		8
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2019
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • subjects who suffer from acute leukemic subjects who accept chemotherapy within one month and will be pretreated by whole-body irradiation peripheral blood cells of subjects are approximate to those of healthy person aged between 18 and 50 years old subjects who are competent to give written informed consent subjects without other systemic diseases

Exclusion Criteria:

  • subjects who suffer from serious other systemic diseases subjects who are unwilling or unable to cooperate with this clinical study other serious cases that probably hinder this clinical study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03928782
Other Study ID Numbers KY-2018-4-26
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Affiliated Hospital to Academy of Military Medical Sciences
Study Sponsor Affiliated Hospital to Academy of Military Medical Sciences
Collaborators Not Provided
Investigators
Study Chair: Lu rongjian, doctor Chinese PLA 307 Hospital
Study Director: Guo biao, master Chinese PLA 307 Hospital
PRS Account Affiliated Hospital to Academy of Military Medical Sciences
Verification Date April 2019

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