Radiation Injuries, ExperimentalNCT03928782
Dose-effect Relationship Between microRNAs in Peripheral Blood and Radiation Injury
An observational study of Radiation Injuries, Experimental, run by Affiliated Hospital to Academy of Military Medical Sciences at 2 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Radiation Injuries, Experimental
- What is being tested?
- 5 Gy or 10 Gy units of whole-body radiation
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2018to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
Study population: Acute leukemic patients after chemotherapy,who will be pretreated by whole-body irradiation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Chiese PLA 307 hospital
Beijing, Beijing Municipality, 100071
rongjian Lu, doctor, 0086-010-66947334, 13426301158@163.com
- Recruiting
Chiese PLA 307 hospital
Beijing, Beijing Municipality, 100071
lu rongjian, doctor, 0086-010-66947334, 13426301158@163.com
About this study
Official title: Study on Dose-effect Relationship Between Radiation Injury Dose and Expression of Associated microRNAs in Human Peripheral Blood
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.
- Conditions
- Radiation Injuries, Experimental
- Being tested
- 5 Gy or 10 Gy units of whole-body radiation
- Keywords
- Radiation Injuries, microRNA
- Medical subject headings
- Radiation Injuries, Experimental, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 Gy or 10 Gy units of whole-body radiationRadiation
8 subjects will be received 5 Gy units of whole-body radiation or 10 Gy units of whole-body radiation.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start1 Dec 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation Injuries, ExperimentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lu rongjian, doctor, Study chair, Chinese PLA 307 HospitalGuo biao, master, Study director, Chinese PLA 307 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928782
- Sponsor's protocol ID
- KY-2018-4-26
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2019
- Last updated
- 26 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Dose-effect Relationship Between Radiation Injury Dose and Expression of Associated microRNAs in Human Peripheral Blood
- ClinicalTrials.gov ID
- NCT03928782
- Acronym / sponsor ID
- KY-2018-4-26
- Conditions
- Radiation Injuries, Experimental
- Keywords
- Radiation Injuries, microRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Acute leukemic patients after chemotherapy,who will be pretreated by whole-body irradiation
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 Gy or 10 Gy units of whole-body radiation8 subjects will be received 5 Gy units of whole-body radiation or 10 Gy units of whole-body radiation. | Radiation | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu rongjian, doctor study chair
Chinese PLA 307 Hospital
Guo biao, master study director
Chinese PLA 307 Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Injuries, Experimental, run by Affiliated Hospital to Academy of Military Medical Sciences at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guo biao, master (0086-010-66947095, 418406096@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expression levels of the microRNAs (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.