Blood Stem Cell Harvest FailureNCT02023814
Peripheral Blood CD34-positive Cells Enumeration as Predictor of Stem Cell Harvest
An observational study of Blood Stem Cell Harvest Failure, run by Ospedale Santa Croce-Carle Cuneo.
Trial summary
Stem cell mobilization procedures after chemotherapy and G-CSf performed at our Institution between 2002 and 2013 were reviewed in order to define prognostic factors for optimal harvest Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Blood Stem Cell Harvest Failure
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Oct 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent mobilization
Who may be able to join
- Mobilization with chemotherapy and G-CSF
- Years 2002-2013
Who cannot join
- mobilization with G-CSF alone
- mobilization with plerixafor
About this study
Official title: Peripheral Blood CD34+ Cells Count as Predictor of Stem Cell Harvest After Chemotherapy and G-CSF. A Single Center Experience
Stem cell mobilization procedures after chemotherapy and G-CSf performed at our Institution between 2002 and 2013 were reviewed in order to define prognostic factors for optimal harvest
- Conditions
- Blood Stem Cell Harvest Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | All patients who underwent stem cell mobilization after chemotherapy and G-CSF at our institution between 2002 and 2013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Stem cell harvest failure rate
Patients not able to harvest at least 2x10e6 CD34+/Kg in the specified time frame are considered failures
Measured: 7 days from hematological recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJan 2002
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Stem Cell Harvest FailureStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Croce-Carle Cuneo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Sorasio, Ospedale Santa Croce-Carle Cuneo
- Investigators
- Roberto Sorasio, Principal investigator, Ospedale S Croce e Carle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023814
- Sponsor's protocol ID
- Emato_aferesi
- Status last verified
- Dec 2013
- First submitted
- 19 Dec 2013
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Blood CD34+ Cells Count as Predictor of Stem Cell Harvest After Chemotherapy and G-CSF. A Single Center Experience
- ClinicalTrials.gov ID
- NCT02023814
- Acronym / sponsor ID
- Emato_aferesi
- Conditions
- Blood Stem Cell Harvest Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Ospedale Santa Croce-Carle CuneoUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Dec 2013 (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.
Stem cell mobilization procedures after chemotherapy and G-CSf performed at our Institution between 2002 and 2013 were reviewed in order to define prognostic factors for optimal harvest
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –All patients who underwent stem cell mobilization after chemotherapy and G-CSF at our institution between 2002 and 2013 |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent mobilization
Key inclusion criteria (2 listed)
- Mobilization with chemotherapy and G-CSF
- Years 2002-2013
Key exclusion criteria (2 listed)
- mobilization with G-CSF alone
- mobilization with plerixafor
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
Blood Stem cell harvest failure rate
Time frame: 7 days from hematological recovery
Patients not able to harvest at least 2x10e6 CD34+/Kg in the specified time frame are considered failures
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 30 Dec 2013.
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.
Roberto Sorasio principal investigator
Ospedale S Croce e Carle
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Stem Cell Harvest Failure, run by Ospedale Santa Croce-Carle Cuneo.
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 2 inclusion and 2 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 30 Dec 2013. 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 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?
Blood Stem cell harvest failure rate (time frame: 7 days from hematological recovery). 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 30 Dec 2013.