NCT02023814

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
Last Updated

December 30, 2013

Status Verified

December 1, 2013

Enrollment Period

11.8 years

First QC Date

December 19, 2013

Last Update Submit

December 24, 2013

Conditions

Blood Stem Cell Harvest Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Study group

All patients who underwent stem cell mobilization after chemotherapy and G-CSF at our institution between 2002 and 2013

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent mobilization

You may qualify if:

  • Mobilization with chemotherapy and G-CSF
  • Years 2002-2013

You may not qualify if:

  • mobilization with G-CSF alone
  • mobilization with plerixafor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Roberto Sorasio

    Ospedale S Croce e Carle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 19, 2013

First Posted

December 30, 2013

Study Start

January 1, 2002

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

December 30, 2013

Record last verified: 2013-12