Studying Umbilical Cord Blood From African-American Donors | NCT00717535

Studies
Studying Umbilical Cord Blood From African-American Donors

NCT00717535

Sponsor

Barbara Ann Karmanos Cancer Institute

Status

Withdrawn

Last Update Posted

Apr 29, 2013Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Health Status Unknown

Interventions

cryopreservation
questionnaire administration
study of socioeconomic and demographic variables

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

Secondary IDs

ID	Type	Description	Link
P30CA022453	U.S. NIH Grant/Contract		View source
WSU-C-2933
WSU-W81XWH-05-1-0266
WSU-024405MP4E	Other Identifier	Wayne State University - Human Investigation Committee
WSU-0505001823	Other Identifier	Wayne State University - Human Investigation Committee

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding unavailable

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Jul 16, 2008

First Submission Date that Met QC Criteria

Jul 16, 2008

First Posted Date

Jul 17, 2008Estimated

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

Apr 25, 2013

Last Update Posted Date

Apr 29, 2013Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

RATIONALE: Studying umbilical cord blood in the laboratory and gathering information about current and previous pregnancies from African-American umbilical cord blood donors may help doctors learn more about the umbilical cord blood of these donors.

PURPOSE: This clinical trial is looking at umbilical cord blood from African-American donors.

Detailed Description

OBJECTIVES:

To correlate the total nucleated cell yield of cord blood units from African-American cord blood donors with gestational history, maternal history, and delivery information.

OUTLINE: This is a multicenter study.

Donors complete questionnaires about their demographics, maternal history, gestational history, and delivery. Cord blood units (CBU) are collected in utero and transported to the Stem Cell Processing Laboratory where they are evaluated for CBU volume and cell count (i.e., total nucleated cell yield) and cryopreserved. The study results will then be used to devise future interventional strategies to improve the yield of nucleated cells of CBU.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between total nucleated cell yield of cord blood units and gestational history, maternal history, and delivery information		Within a year
Improvement in total nucleated cell yield of cord blood units from African-American donors		Within a year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

African-American participant in the National Marrow Donor Program cord blood collection protocol C-2844
Recruited from the Labor and Delivery Suites of the Detroit Medical Center or its affiliated sites

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

African American cord blood donors

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Voravit Ratanatharathorn, MD	Barbara Ann Karmanos Cancer Institute	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015925	Cryopreservation

Ancestor Terms

ID	Term
D014021	Tissue Preservation
D016591	Histocytological Preparation Techniques
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
cryopreservation	Other
questionnaire administration	Other
study of socioeconomic and demographic variables	Other