NCT01231022

Completed

Study the Role of Stem Cell in Curing Drug Induced Liver Inj...

Peking University Cancer Hospital & Institute Source

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Other study identifiers

Sponsor study identifier

DILI

Study Type

observational

Actual enrollment (reported)

52

Locations

1 country

Sites

1

Timeline

Study Start

August 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2011

Actual (reported)

Study Completion

June 2013

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 52 participants
Study completion date: June 2013
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 20, 2010
Actual (reported)
First Posted
November 1, 2010
Actual (reported)
Primary Completion
June 2011
Actual (reported)
Study Completion
June 2013
Actual (reported)

Last Updated: July 29, 2015
Status Verified: July 2015
Last Update Submitted: July 27, 2015

Conditions

Breast Neoplasms Neoplasm 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;

Sponsors & Collaborators

Peking University Cancer Hospital & Institute
Otherlead

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

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 Disorders

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

Enrollment

52 participants (actual enrollment reported by the registry).

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 2010

Date type not reported

This date has not been verified as actual or estimated.

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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.

Poisoning

Primary Completion

June 2011

Actual (reported)

Study Completion

June 2013

Actual (reported)

Last Updated

July 29, 2015

Record last verified: 2015-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01231022
Data provider: ClinicalTrials.gov
Source updated: 2015-07-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:52 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations