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

Completed

• Conditions: Breast Neoplasms; Neoplasm Metastasis

• Registration Number: NCT01231022
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-29
• Study First Posted: 2010-11-01
• Primary Completion: 2011-06
• Study Completion: 2013-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China