- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02023814
Peripheral Blood CD34-positive Cells Enumeration as Predictor of Stem Cell Harvest
December 24, 2013 updated by: Roberto Sorasio, Ospedale Santa Croce-Carle Cuneo
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
250
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent mobilization
Description
Inclusion Criteria:
- Mobilization with chemotherapy and G-CSF
- Years 2002-2013
Exclusion Criteria:
- mobilization with G-CSF alone
- mobilization with plerixafor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Study group
All patients who underwent stem cell mobilization after chemotherapy and G-CSF at our institution between 2002 and 2013
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
7 days from hematological recovery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roberto Sorasio, Ospedale S Croce e Carle
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
December 19, 2013
First Submitted That Met QC Criteria
December 24, 2013
First Posted (Estimate)
December 30, 2013
Study Record Updates
Last Update Posted (Estimate)
December 30, 2013
Last Update Submitted That Met QC Criteria
December 24, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- Emato_aferesi
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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