Health Status UnknownNCT00717535
Studying Umbilical Cord Blood From African-American Donors
An observational study of Health Status Unknown, run by Barbara Ann Karmanos Cancer Institute.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Status Unknown
- What is being tested?
- cryopreservation, questionnaire administration and study of socioeconomic and demographic variables
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: African American cord blood donors
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
About this study
Official title: Investigation of the Total Nucleated Cell Yield of Cord Blood Units Collected From African-American Donors in Correlation With Gestational and Other Health Variables
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.
Read the 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.
- Conditions
- Health Status Unknown
- Being tested
- cryopreservation, questionnaire administration, study of socioeconomic and demographic variables
- Keywords
- health status unknown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryopreservationOther
questionnaire administrationOther
study of socioeconomic and demographic variablesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between total nucleated cell yield of cord blood units and gestational history, maternal history, and delivery information
Measured: Within a year
Improvement in total nucleated cell yield of cord blood units from African-American donors
Measured: Within a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startAug 2005
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Status UnknownStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Voravit Ratanatharathorn, MD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717535
- Sponsor's protocol ID
- CDR0000598111
- Other IDs
- P30CA022453, WSU-C-2933, WSU-W81XWH-05-1-0266, WSU-024405MP4E, WSU-0505001823
- Status last verified
- Apr 2013
- First submitted
- 16 Jul 2008
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Total Nucleated Cell Yield of Cord Blood Units Collected From African-American Donors in Correlation With Gestational and Other Health Variables
- ClinicalTrials.gov ID
- NCT00717535
- Acronym / sponsor ID
- CDR0000598111
- Conditions
- Health Status Unknown
- Keywords
- health status unknown
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 17 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- African American cord blood donors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryopreservation | Other | – |
| questionnaire administration | Other | – |
| study of socioeconomic and demographic variables | Other | – |
Primary outcome
Correlation between total nucleated cell yield of cord blood units and gestational history, maternal history, and delivery information
Time frame: Within a year
Improvement in total nucleated cell yield of cord blood units from African-American donors
Time frame: Within a year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Voravit Ratanatharathorn, MD principal investigator
Barbara Ann Karmanos Cancer Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Health Status Unknown, run by Barbara Ann Karmanos Cancer Institute.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between total nucleated cell yield of cord blood units and gestational history, maternal history, and delivery information (time frame: Within a year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2013.