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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01231022
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):
Jun Ren, Beijing Cancer Hospital

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.

Condition or disease
Breast Neoplasms Neoplasm Metastasis

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.

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Study the Role of Stem Cell in Curing Drug Induced Liver Injury in Metastatic Breast Cancer
Study Start Date : August 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. SNPs genotyping associated with Drug Induced Liver Injury [ Time Frame: 3 months ]
    Some SNPs will be find to associated with DILI.

  2. Change of cytokines [ Time Frame: 3 months ]
    Changes of cytokines in periphral blood related with liver function with be observed.


Biospecimen Retention:   None Retained
patients' blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
female patients with metastatic breast cancer
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231022


Locations
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China
Beijing Cancer Hospital
Beijing, China, 100142
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
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Principal Investigator: XU LIANG, MD and PhD Beijing Cancer Hospital
Study Chair: JUN REN, MD and PhD Beijing Cancer Hospital
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Responsible Party: Jun Ren, Director, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT01231022    
Other Study ID Numbers: DILI
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015
Keywords provided by Jun Ren, Beijing Cancer Hospital:
breast neoplasm
Neoplasm Metastasis
Stem Cells
Drug-Induced Liver Injury
Additional relevant MeSH terms:
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Neoplasm Metastasis
Breast Neoplasms
Chemical and Drug Induced Liver Injury
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning