Liver CancerNCT00605800
Bone Marrow Derived Adult Liver Stem Cell Recruitment After Major Liver Resections: Correlation With Liver Regeneration and Hepatic Function
An observational study of Liver Cancer, run by Memorial Sloan Kettering Cancer Center.
Trial summary
The results of this study may or may not establish useful baseline data, which will help us understand how bone marrow derived adult liver stem cells behave in normal healthy adults/volunteers (the control group), and in patients undergoing liver surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Cancer
- What is being tested?
- blood drawn
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Mar 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: MSKCC clinics Normal healthy volunteers
Who may be able to join
- Adults (≥ or equal to 18 years old).
- Patients scheduled for resection of 3 or more liver segments for any indication, with or without other planned procedures.
- Or
- Normal healthy volunteers (control).
Who cannot join
- Chemotherapy or GCSF treatment in the preceding 4 weeks.
- CHILD'S classification B or above.
- Presence of active infection.
- History of lymphoma or leukemia.
- Normal healthy volunteers who underwent chemotherapy treatment at any stage of their life will be excluded.
- Normal healthy volunteers who are under any active treatment for any active illness will be excluded.
About this study
The results of this study may or may not establish useful baseline data, which will help us understand how bone marrow derived adult liver stem cells behave in normal healthy adults/volunteers (the control group), and in patients undergoing liver surgery. The bone marrow is located within your bones and is the organ which is responsible to produce blood cells and stem cells. Bone marrow derived adult liver stem cells are normal cells in your bone marrow. These liver stem cells have the capacity to regenerate or in other words to rebuild the liver after liver surgery, a process called liver regeneration. These cells are very important for the liver to regrow its tissue after liver surgery. These cells are thought to be activated in times of need by the liver.
Situations like liver surgery are one of these occasions when the liver will need the "extra help" from these stem cells.
The results of this study will establish the baseline data necessary for the understanding of how to harness the ability of these stem cells in times of liver surgery. Improvements in the ability of the liver to regrow after surgery is thought to decrease complications related to liver surgery. Harnessing this unique ability of stem cells may be utilized in the future to enhance the regrowing process of liver tissue after liver surgery, called liver regeneration.
- Conditions
- Liver Cancer
- Being tested
- blood drawn
- Keywords
- Liver resection
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawnOther
Baseline levels of bone marrow derived liver stem cells from normal healthy volunteers, which will be drawn once Two 5ml blue tubes).
blood drawnOther
At the time of preoperative testing, patients will have two extra test tubes (5cc blue top) of blood drawn for determination of pre-operative base line levels of bone marrow derived liver stem cells in peripheral blood. Intraoperatively, blood will be drawn after liver resection (two tubes of 5cc blue top). Two extra tube of blood will be drawn at the same time of routine postoperative blood drawing to determine levels of bone marrow derived liver stem cells in peripheral blood on post-operative days #1, and #3.
| Study group | Role | What they receive |
|---|---|---|
| 1 | normal healthy volunteers Receives: Other: blood drawn | |
| 2 | Patients undergoing major liver resections Receives: Other: blood drawn |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine qualitatively and quantitatively whether bone marrow derived liver associated stem cells are mobilized from the bone marrow in patients undergoing major liver resections (3 or more liver segments).
Measured: conclusion of study
Secondary outcomes (1)
To determine whether a difference exist in the baseline levels of bone marrow derived liver associated stem cells between normal healthy subjects/ volunteers and cancer patients prior to liver surgery.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startMar 2006
- Primary completionMar 2009 (estimated)
- Study completionMar 2009 (estimated)
Why it stopped: Study was closed due to logistical issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Ronald DeMatteo, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605800
- Sponsor's protocol ID
- 06-017
- Status last verified
- Mar 2009
- First submitted
- 17 Jan 2008
- Last updated
- 19 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Derived Adult Liver Stem Cell Recruitment After Major Liver Resections: Correlation With Liver Regeneration and Hepatic Function
- ClinicalTrials.gov ID
- NCT00605800
- Acronym / sponsor ID
- 06-017
- Conditions
- Liver Cancer
- Keywords
- Liver resection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was closed due to logistical issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2006
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 31 Jan 2008 (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 results of this study may or may not establish useful baseline data, which will help us understand how bone marrow derived adult liver stem cells behave in normal healthy adults/volunteers (the control group), and in patients undergoing liver surgery. The bone marrow is located within your bones and is the organ which is responsible to produce blood cells and stem cells. Bone marrow derived adult liver stem cells are normal cells in your bone marrow. These liver stem cells have the capacity to regenerate or in other words to rebuild the liver after liver surgery, a process called liver regeneration. These cells are very important for the liver to regrow its tissue after liver surgery. These cells are thought to be activated in times of need by the liver.
Situations like liver surgery are one of these occasions when the liver will need the "extra help" from these stem cells.
The results of this study will establish the baseline data necessary for the understanding of how to harness the ability of these stem cells in times of liver surgery. Improvements in the ability of the liver to regrow after surgery is thought to decrease complications related to liver surgery. Harnessing this unique ability of stem cells may be utilized in the future to enhance the regrowing process of liver tissue after liver surgery, called liver regeneration.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: blood drawnnormal healthy volunteers |
| 2 | – | Other: blood drawnPatients undergoing major liver resections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- MSKCC clinics Normal healthy volunteers
Key inclusion criteria (4 listed)
- Adults (≥ or equal to 18 years old).
- Patients scheduled for resection of 3 or more liver segments for any indication, with or without other planned procedures.
- Or
- Normal healthy volunteers (control).
Key exclusion criteria (6 listed)
- Chemotherapy or GCSF treatment in the preceding 4 weeks.
- CHILD'S classification B or above.
- Presence of active infection.
- History of lymphoma or leukemia.
- Normal healthy volunteers who underwent chemotherapy treatment at any stage of their life will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawnBaseline levels of bone marrow derived liver stem cells from normal healthy volunteers, which will be drawn once Two 5ml blue tubes). | Other | 1 |
| blood drawnAt the time of preoperative testing, patients will have two extra test tubes (5cc blue top) of blood drawn for determination of pre-operative base line levels of bone marrow derived liver stem cells in peripheral blood. Intraoperatively, blood will be drawn after liver resection (two tubes of 5cc blue top). Two extra tube of blood will be drawn at the same time of routine postoperative blood drawing to determine levels of bone marrow derived liver stem cells in peripheral blood on post-operative days #1, and #3. | Other | 2 |
Primary outcome
To determine qualitatively and quantitatively whether bone marrow derived liver associated stem cells are mobilized from the bone marrow in patients undergoing major liver resections (3 or more liver segments).
Time frame: conclusion of study
1 secondary outcome
To determine whether a difference exist in the baseline levels of bone marrow derived liver associated stem cells between normal healthy subjects/ volunteers and cancer patients prior to liver surgery.
Time frame: conclusion of study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2009.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Ronald DeMatteo, MD principal investigator
Memorial Sloan Kettering Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by Memorial Sloan Kettering Cancer Center.
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 6 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: withdrawn, as of the sponsor's last update on 19 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
To determine qualitatively and quantitatively whether bone marrow derived liver associated stem cells are mobilized from the bone marrow in patients undergoing major liver resections (3 or more liver segments). (time frame: conclusion of study). 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 19 Mar 2009.