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NCT Number: NCT01231022

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Chemical and Drug Induced Liver Injury Chemically-Induced Disorders Digestive System Diseases Drug-Related Side Effects and Adverse Reactions Liver Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Poisoning Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Beijing Cancer Hospital

Beijing, 100142, China

About this study

  • The researcher investigate the incidence and the cause of Drug Induced Liver Injury in MBC.
  • Patients having a complete clinical history and physical examination, receive routine chemotherapy.
  • Venous blood Sample(4 ml)is collected before and after each cycle according to the planning time.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

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

Acronym: MBC

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Nov 1, 2010
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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