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

Breast Neoplasms Clinical Trial

— MBC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231022
• Other study ID #: DILI
• Status: Completed
• Phase: N/A
• First received: October 20, 2010
• Last updated: July 27, 2015
• Start date: August 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2015
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Neoplasms
• Drug-Induced Liver Injury
• Neoplasm Metastasis
• Neoplasms

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protective effection of peripheral hematopoietic stem cell infusion for DILI	Patients receiving PHSC infusion after chemotherapy will have lower incidence of DILI. PHSC infusion may improve the liver function.	3 months	Yes
Secondary	SNPs genotyping associated with Drug Induced Liver Injury	Some SNPs will be find to associated with DILI.	3 months	Yes
Secondary	Change of cytokines	Changes of cytokines in periphral blood related with liver function with be observed.	3 months	Yes