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

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ClinicalTrials.gov Identifier: NCT03928782
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

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

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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

Intervention Details:
  • 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.


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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Acute leukemic patients after chemotherapy,who will be pretreated by whole-body irradiation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928782


Contacts
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Contact: Guo biao, master 0086-010-66947095 418406096@qq.com
Contact: Lu rongjian, doctor 0086-010-66947334 13426301158@163.com

Locations
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China, Beijing
Chiese PLA 307 hospital Recruiting
Beijing, Beijing, China, 100071
Contact: rongjian Lu, doctor    0086-010-66947334    13426301158@163.com   
Chiese PLA 307 hospital Recruiting
Beijing, Beijing, China, 100071
Contact: lu rongjian, doctor    0086-010-66947334    13426301158@163.com   
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Investigators
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Study Chair: Lu rongjian, doctor Chinese PLA 307 Hospital
Study Director: Guo biao, master Chinese PLA 307 Hospital

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Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT03928782     History of Changes
Other Study ID Numbers: KY-2018-4-26
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences:
Radiation Injuries
microRNA

Additional relevant MeSH terms:
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Wounds and Injuries
Radiation Injuries
Radiation Injuries, Experimental