Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy
29 mars 2017 uppdaterad av: Li Qiao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy. - an Open , Multicenter, Non-interventional Clinical Trial
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.
Studieöversikt
Status
Okänd
Betingelser
Detaljerad beskrivning
The endorsed standard serum biomarkers, like ALT, AST, total bilirubin, are not tissue-specific, and cannot detect drug-induced liver injury (DILI) at a very early stage, thus unable to properly guide risk assessment and patient management.
miR-122 is a liver-enriched miRNA.
Many studies have demonstrated that miR-122 is a sensitive and specific biomarker when DILI occurred.
However, there is a lack of a standard quantification method for miR-122 and confirmatory studies using a comprehensive list of drugs and patients.
The investigators have developed the miRNA-derived Fragment Length Polymorphism (miRFLP) assay for the simultaneous quantification of multiple miRNAs.The methodology improves detection reliability by eliminating intra-assay variables.
In this study, the investigators will investigate the role of miR-122 as a real-time detection biomarker of drug-induced liver injury utilizing the miRFLP assay.
In addition, the investigators will try to identify the normal physiological range of miR-122 in healthy population and the relationship of miR-122 and hepatic failure in patients of intensive care unit.
Studietyp
Observationell
Inskrivning (Förväntat)
180
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Binghe Xu, MD,PHD
- Telefonnummer: 86-87788826
- E-post: xubinghe@medmail.com
Studera Kontakt Backup
- Namn: Qiao Li, MD
- Telefonnummer: 86-87788120
- E-post: liqiaopumc@qq.com
Studieorter
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Beijing
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Beijing, Beijing, Kina, 100021
- Rekrytering
- Cancer Hospital, ChineseAMS
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Kontakt:
- Qiao LI, MD
- Telefonnummer: 86-10-87788120
- E-post: liqiaopumc@yahoo.cn
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Kontakt:
- Binghe XU, MD, PHD
- Telefonnummer: 86-10-87788495
- E-post: xubinghe@medmail.com.cn
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
We recuit 3 groups of people: people with malignant tumor who will receive their first cycle of chemotherapy, healthy population and patients in intensive care unit
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Chemotherapy group
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.
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Healthy population
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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Relationship of serum miR-122 level and DILI or hepatic failure
Tidsram: 1 year
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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.
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1 year
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Normal physiological range of miR-122 in healthy population
Tidsram: 1 years
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To determine a primary normal physiological range of serum miR-122 level (copies/uL) in a group of 20 healthy women and/or men.
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1 years
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Binghe Xu, MD,PHD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2016
Primärt slutförande (Förväntat)
1 juli 2017
Avslutad studie (Förväntat)
1 juli 2017
Studieregistreringsdatum
Först inskickad
8 januari 2017
Först inskickad som uppfyllde QC-kriterierna
31 januari 2017
Första postat (Uppskatta)
1 februari 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 mars 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 mars 2017
Senast verifierad
1 januari 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LQ003
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .