Study the Role of Stem Cell in Curing Drug Induced Liver... | NCT01231022

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

NCT01231022

Sponsor

Peking University Cancer Hospital & Institute

Status

Completed

Last Update Posted

Jul 29, 2015Estimated

Enrollment

52Actual

Phase

Not provided

Conditions

Breast Neoplasms
Neoplasm Metastasis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2013Actual

First Submitted Date

Oct 20, 2010

First Submission Date that Met QC Criteria

Oct 29, 2010

First Posted Date

Nov 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2015

Last Update Posted Date

Jul 29, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun Ren, Director, Peking University Cancer Hospital & InstitutePrincipal Investigator

Lead Sponsor

Peking University Cancer Hospital & InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

52Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
SNPs genotyping associated with Drug Induced Liver Injury	Some SNPs will be find to associated with DILI.	3 months
Change of cytokines	Changes of cytokines in periphral blood related with liver function with be observed.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

female patients with metastatic breast cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
XU LIANG, MD and PhD	Peking University Cancer Hospital & Institute	Principal Investigator
JUN REN, MD and PhD	Peking University Cancer Hospital & Institute	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Cancer Hospital		Beijing		100142	China

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D009362	Neoplasm Metastasis
D056486	Chemical and Drug Induced Liver Injury

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided