Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy
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|ClinicalTrials.gov Identifier: NCT03039062|
Recruitment Status : Unknown
Verified January 2017 by Li Qiao, Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : February 1, 2017
Last Update Posted : March 30, 2017
|Condition or disease|
|Chemotherapeutic Toxicity Malignant Tumor Liver Injury|
|Study Type :||Observational|
|Estimated Enrollment :||180 participants|
|Official Title:||Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy. - an Open , Multicenter, Non-interventional Clinical Trial|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
A total of 120 malignant tumor patients who need to receive chemotherapy are involved for miR-122 detection. They are from 3 centers, 40 for each center. For the first cycle of chemotherapy, the investigators will collect 0.5-1ml blood from the remained blood sample after routine blood test during chemotherapy for each patient.Each patient will have a routine blood test before(±3 days) each cycle of chemotherapy and 7(±3)days after chemotherapy. A routine blood test will include the test of ALT,AST,ALP and TBIL. Sample collection will stop after 4 cycles of chemotherapy. All blood samples collected by investigators are the remained sample after routine tests. Patients in routine care will also have blood tests before each cycle and on day 7(+/- 3) of each cycle of chemotherapy. These patients will also have blood test at these time points even if they are not in this trial.
Twenty healthy women or men who come to hospitals for annual physical examinations are enrolled in this study for miR-122 detection. Investigators will collect 0.5-1 ml blood from the remained blood samples after routine blood tests during their annual physical examinations.
Patients of intensive care unit
Fourty patients are enrolled in this group for miR-122 detection. The investigators will collect 0.5-1ml blood from the remained blood samples of their routine blood tests or when they need blood tests.
- Relationship of serum miR-122 level and DILI or hepatic failure [ Time Frame: 1 year ]Serum miR-122 level (copies/uL) and liver function (such as ALT, AST, ALP, and bilirubin levels) will be tested before and after each cycle of chemotherapy, and the relationship of serum miR-122 level fluctuation and liver injury will be investigated.
- Normal physiological range of miR-122 in healthy population [ Time Frame: 1 years ]To determine a primary normal physiological range of serum miR-122 level (copies/uL) in a group of 20 healthy women and/or men.
Biospecimen Retention: Samples With DNA
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): NCT03039062
|Contact: Binghe Xu, MD,PHDfirstname.lastname@example.org|
|Contact: Qiao Li, MDemail@example.com|
|Cancer Hospital, ChineseAMS||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: Qiao LI, MD 86-10-87788120 firstname.lastname@example.org|
|Contact: Binghe XU, MD, PHD 86-10-87788495 email@example.com|
|Principal Investigator:||Binghe Xu, MD,PHD||Chinese Academy of Medical Sciences|