Cancer Stem Cells in Multiple Myeloma | NCT01820546

Studies
Cancer Stem Cells in Multiple Myeloma

NCT01820546

Sponsor

Ankara University

Status

Completed

Last Update Posted

Jan 6, 2016Estimated

Enrollment

96Actual

Phase

Not provided

Conditions

Multiple Myeloma

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Jan 2016

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 2013

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Mar 26, 2013

First Submission Date that Met QC Criteria

Mar 26, 2013

First Posted Date

Mar 28, 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

Jan 4, 2016

Last Update Posted Date

Jan 6, 2016Estimated

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

In multiple myeloma "cancer stem" cells can be defined and quantified with flow cytometry. More, these cells can be related to treatment response.

Detailed Description

The investigators' hypothesis is that, multiple myeloma plasma cells derivate from principal cells that is called "cancer or progenitor stem cell". In multiple myeloma to define immunophenotyping features of these "cancer stem cells" with flow cytometry and to show their prognostic value and check for any relationship between cancer stem cell quantification and chemotherapy response are main aims of this study.

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

Retention

Enrollment

96Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment Response	After 3 courses chemotherapy treatment response	3 months

Secondary Outcomes

Measure	Description	Time Frame
Treatment Response	After 6 courses chemotherapy treatment response	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

New Diagnosed or Relapsed Multiple Myeloma
Routine Bone Marrow Aspiration will be done

Exclusion Criteria:

Bone Marrow Aspiration is not Needed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

New Diagnosed or Relapsed Multiple Myeloma Patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mehmet Ozen, MD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara University Hematology Unit		Ankara		06590	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14630803	Background	Matsui W, Huff CA, Wang Q, Malehorn MT, Barber J, Tanhehco Y, Smith BD, Civin CI, Jones RJ. Characterization of clonogenic multiple myeloma cells. Blood. 2004 Mar 15;103(6):2332-6. doi: 10.1182/blood-2003-09-3064. Epub 2003 Nov 20.

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders