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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01231022

Acronym

MBC

Enrollment

Registered

2010-11-01

Start date

2010-08-31

Completion date

2013-06-30

Last updated

2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Neoplasm Metastasis

Keywords

breast neoplasm, Neoplasm Metastasis, Stem Cells, Drug-Induced Liver Injury

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results