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

NCT ID: NCT01231022

Last Updated: 2015-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms Neoplasm Metastasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Jun Ren

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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XU LIANG, MD and PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

JUN REN, MD and PhD

Role: STUDY_CHAIR

Peking University Cancer Hospital & Institute

Locations

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Beijing Cancer Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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DILI

Identifier Type: -

Identifier Source: org_study_id

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