Study the Role of Stem Cell in Curing Drug Induced Liver Injury in Metastatic Breast Cancer (MBC)

Overview

The investigators want to know the role of Peripheral hematopoietic stem cell infusion in avoiding Drug Induced Liver Injury,and also try to research SNPs genotyping associated with Drug Induced Liver Injury.

Full Title of Study: “Study the Role of Stem Cell in Curing Drug Induced Liver Injury in Metastatic Breast Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: June 2011

Detailed Description

1. The researcher investigate the incidence and the cause of Drug Induced Liver Injury in MBC. 2. Patients having a complete clinical history and physical examination, receive routine chemotherapy. 3. Venous blood Sample(4 ml)is collected before and after each cycle according to the planning time. 4. Genomic DNA,RNA and upper serum is isolated. ELISA、rt-PCR or PCR-direct sequencing is used to detect the protein or gene expression associated with liver function.

Clinical Trial Outcome Measures

Primary Measures

  • Protective effection of peripheral hematopoietic stem cell infusion for DILI
    • Time Frame: 3 months
    • Patients receiving PHSC infusion after chemotherapy will have lower incidence of DILI. PHSC infusion may improve the liver function.

Secondary Measures

  • SNPs genotyping associated with Drug Induced Liver Injury
    • Time Frame: 3 months
    • Some SNPs will be find to associated with DILI.
  • Change of cytokines
    • Time Frame: 3 months
    • Changes of cytokines in periphral blood related with liver function with be observed.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients should be histologically confirmed with metastatic breast cancer; – an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; – Normal cardiac, hepatic, renal and bone marrow functions; – Life expectancy ≥3 months; Exclusion Criteria:

  • previous history of other malignancies; – Central nervous system metastases; – Serious or uncontrolled concurrent medical illness.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking University Cancer Hospital & Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jun Ren, Director – Peking University Cancer Hospital & Institute
  • Overall Official(s)
    • XU LIANG, MD and PhD, Principal Investigator, Peking University Cancer Hospital & Institute
    • JUN REN, MD and PhD, Study Chair, Peking University Cancer Hospital & Institute

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