Peripheral Blood CD34-positive Cells Enumeration as Predi... | NCT02023814

Studies
Peripheral Blood CD34-positive Cells Enumeration as Predictor of Stem Cell Harvest

NCT02023814

Sponsor

Ospedale Santa Croce-Carle Cuneo

Status

Completed

Last Update Posted

Dec 30, 2013Estimated

Enrollment

250Actual

Phase

Not provided

Conditions

Blood Stem Cell Harvest Failure

Interventions

Not provided

Countries

Not provided

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

Dec 2013

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

Jan 2002

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Dec 19, 2013

First Submission Date that Met QC Criteria

Dec 24, 2013

First Posted Date

Dec 30, 2013Estimated

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

Dec 24, 2013

Last Update Posted Date

Dec 30, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		All patients who underwent stem cell mobilization after chemotherapy and G-CSF at our institution between 2002 and 2013

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Stem cell harvest failure rate	Patients not able to harvest at least 2x10e6 CD34+/Kg in the specified time frame are considered failures	7 days from hematological recovery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mobilization with chemotherapy and G-CSF
Years 2002-2013

Exclusion Criteria:

mobilization with G-CSF alone
mobilization with plerixafor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who underwent mobilization

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roberto Sorasio	Ospedale S Croce e Carle	Principal Investigator

Locations

Not provided