NCT01231022

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

10 months

First QC Date

October 20, 2010

Last Update Submit

July 27, 2015

Conditions

Breast NeoplasmsNeoplasm Metastasis

Keywords

breast neoplasmNeoplasm MetastasisStem CellsDrug-Induced Liver Injury

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • SNPs genotyping associated with Drug Induced Liver Injury

    3 months

  • Change of cytokines

    3 months

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

female patients with metastatic breast cancer

You may qualify if:

  • 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;

You may not qualify if:

  • previous history of other malignancies;
  • Central nervous system metastases;
  • Serious or uncontrolled concurrent medical illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

Location

Biospecimen

Retention: NONE RETAINED

patients' blood sample

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm MetastasisChemical and Drug Induced Liver Injury

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Study Officials

  • XU LIANG, MD and PhD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

  • JUN REN, MD and PhD

    Peking University Cancer Hospital & Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 20, 2010

First Posted

November 1, 2010

Study Start

August 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2013

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations

CN(1)