Breast NeoplasmsMBCNCT01231022
Study the Role of Stem Cell in Curing Drug Induced Liver Injury in Metastatic Breast Cancer (MBC)
An observational study of Breast Neoplasms and Neoplasm Metastasis, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasm Metastasis
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: female patients with metastatic breast cancer
Who may be able to join
- 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;
Who cannot join
- previous history of other malignancies;
- Central nervous system metastases;
- Serious or uncontrolled concurrent medical illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study the Role of Stem Cell in Curing Drug Induced Liver Injury in Metastatic Breast Cancer
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.
Read the 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.
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Keywords
- breast neoplasm, Neoplasm Metastasis, Stem Cells, Drug-Induced Liver Injury
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Chemical and Drug Induced Liver Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
SNPs genotyping associated with Drug Induced Liver Injury
Some SNPs will be find to associated with DILI.
Measured: 3 months
Change of cytokines
Changes of cytokines in periphral blood related with liver function with be observed.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ren, Peking University Cancer Hospital & Institute
- Investigators
- XU LIANG, MD and PhD, Principal investigator, Peking University Cancer Hospital & InstituteJUN REN, MD and PhD, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231022
- Sponsor's protocol ID
- DILI
- Acronym
- MBC
- Status last verified
- Jul 2015
- First submitted
- 20 Oct 2010
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Role of Stem Cell in Curing Drug Induced Liver Injury in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01231022
- Acronym / sponsor ID
- MBC / DILI
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Keywords
- breast neoplasm, Neoplasm Metastasis, Stem Cells, Drug-Induced Liver Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female patients with metastatic breast cancer
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (3 listed)
- previous history of other malignancies;
- Central nervous system metastases;
- Serious or uncontrolled concurrent medical illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
SNPs genotyping associated with Drug Induced Liver Injury
Time frame: 3 months
Change of cytokines
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XU LIANG, MD and PhD principal investigator
Peking University Cancer Hospital & Institute
JUN REN, MD and PhD study chair
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Neoplasm Metastasis, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protective effection of peripheral hematopoietic stem cell infusion for DILI (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.