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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03928782
Other study ID # KY-2018-4-26
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date September 1, 2019

Study information

Verified date April 2019
Source Affiliated Hospital to Academy of Military Medical Sciences
Contact Guo biao, master
Phone 0086-010-66947095
Email 418406096@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 8
Est. completion date September 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


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.

Locations

Country Name City State
China Chiese PLA 307 hospital Beijing Beijing
China Chiese PLA 307 hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary expression levels of the microRNAs the expression levels of the microRNAs in human peripheral blood before radiation,12 hours after radiation and 24 hours after radiation 12 hours