Clinical trial · Observational
Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy
Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy. - an Open , Multicenter, Non-interventional Clinical Trial
NCT03039062CI-TRIAL-00026694unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open , multicenter, interventional clinical trial to conform the role of of miR-122 a real-time detection biomarker of drug-induced liver injury by chemotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Liver Injury | — | UNRESOLVED | — |
| Malignant Tumor | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Chemotherapy group
- description
- 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.
- label
- Healthy population
- description
- 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.
- label
- Patients of intensive care unit
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: For all the participants: * Normal liver function biomarkers including ALT,AST,ALP,TBIL before recruitment. * Patients with liver disease:hepatitis B，hepatitis C，cirrhosis, hepatic failure and so on. For patients in chemotherapy group: * Life expectancy at least 12 weeks * 40 patients received epirubicin-containing chemotherapY * 40 patients received paclitaxel-containing chemotherapy * Patients received carboplatin-containing chemotherapy. * Patients with congestive heart failure * Unstable angina pectoris * Previous history of myocardial infarction within 6 month prior to study entry * Uncontrolled hypertension as determined by the Investigator or high risk uncontrolled, arrhythmia. Exclusion Criteria: * Patients previously received chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.