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


N/A
18 Years
70 Years
Open (Enrolling)
Female
Breast Neoplasms, Neoplasm Metastasis

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

Protective effection of peripheral hematopoietic stem cell infusion for DILI

Outcome Description:

Patients receiving PHSC infusion after chemotherapy will have lower incidence of DILI. PHSC infusion may improve the liver function.

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

XU LIANG, MD and PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beijing Cancer Hospital

Authority:

China: Ministry of Health

Study ID:

DILI

NCT ID:

NCT01231022

Start Date:

August 2010

Completion Date:

June 2013

Related Keywords:

  • Breast Neoplasms
  • Neoplasm Metastasis
  • breast neoplasm
  • Neoplasm Metastasis
  • Stem Cells
  • Drug-Induced Liver Injury
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis
  • Drug-Induced Liver Injury

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