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Clinical Trials/NCT01231022
NCT01231022CompletedNot Applicable

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

Peking University Cancer Hospital & Institute1 site in 1 country52 target enrollmentStarted: August 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
52
Locations
1
Primary Endpoint
Protective effection of peripheral hematopoietic stem cell infusion for DILI
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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 Outcomes

  • SNPs genotyping associated with Drug Induced Liver Injury(3 months)
  • Change of cytokines(3 months)

Investigators

Sponsor
Peking University Cancer Hospital & Institute
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jun Ren

Director

Peking University Cancer Hospital & Institute

Study Sites (1)

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