Anemia, Sickle CellGen/PhenNCT00528203
Establishing a Repository of Blood and DNA Samples From People With Sickle Cell Disease (Comprehensive Sickle Cell Centers Collaborative Genotype-Phenotype Database and Sample Repository)
An observational study of Anemia, Sickle Cell, run by National Heart, Lung, and Blood Institute (NHLBI) at 13 sites in United States.
Trial summary
Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. The purpose of this study is to collect, test, and archive blood and DNA samples from children and adults with SCD to study the role that genes play in SCD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anemia, Sickle Cell
- How many people
- 3,640 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2007to Sep 2008
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All adult and pediatric patients who are enrolled in the C-Data project are eligible for this study. (C-Data eligibility: All adult and pediatric patients who have been seen within the last 24 months in the hospital or clinical setting and are expected to return episodically or regularly for care at 1 of the CSCC are eligible for inclusion in the C-Data project.)
Who may be able to join
- Participating in the C-Data project
Who cannot join
- Unable to undergo blood collection
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Children's Hospital of Boston
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Children's Medical Hospital of Dallas
Dallas, Texas, 75235
University of Texas Southwestern & Parkland
Dallas, Texas, 75235
University of Texas at Galveston
Galveston, Texas, 77555
Children's Hospital Oakland
Oakland, California, 94609
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
University of California, San Francisco
San Francisco, California, 94134
Montefiore Medical Center
The Bronx, New York, 10463
About this study
Official title: Comprehensive Sickle Cell Centers (CSCC) Collaborative Genotype-Phenotype Database and Sample Repository
Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. The purpose of this study is to collect, test, and archive blood and DNA samples from children and adults with SCD to study the role that genes play in SCD. Blood and DNA samples will be stored for use in future SCD studies.
Read the detailed description
SCD is an inherited blood disorder that is caused by an abnormal type of hemoglobin. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." The Comprehensive Sickle Cell Centers (CSCC) is a network of 10 centers that conduct research to improve health care and treatment options for people with SCD. The Collaborative Data Project (C-Data) is a CSCC study that is establishing a comprehensive database of children and adults with SCD who are receiving medical care at participating CSCC research centers. This study will initiate the development of a centralized laboratory that will collect, test, and archive blood and DNA samples from participants in the C-Data project for use in future SCD studies. The collection of blood and DNA samples will provide researchers with an important resource to better define the genetic diversity of SCD. In the future, genotype-phenotype correlation studies, population studies, and various other genetic studies may be conducted.
This study will enroll participants taking part in the C-Data project. For this study, participants will undergo a blood collection. The blood sample will then be sent to a lab to characterize the red blood cells and hemoglobin. DNA will be analyzed to identify genes that influence the severity of SCD. Blood and DNA will be stored for future genetic research in SCD and closely related disorders.
- Conditions
- Anemia, Sickle Cell
- Keywords
- Sickle Cell Disease, Sickle Cell Anemia, DNA
- Medical subject headings
- Anemia, Sickle Cell
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Funds for study ended September 30, 2008.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,640 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Carolyn Hoppe, MD, Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528203
- Sponsor's protocol ID
- 517
- Other IDs
- U54HL070587
- Acronym
- Gen/Phen
- Status last verified
- Nov 2008
- First submitted
- 10 Sep 2007
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Sickle Cell Centers (CSCC) Collaborative Genotype-Phenotype Database and Sample Repository
- ClinicalTrials.gov ID
- NCT00528203
- Acronym / sponsor ID
- Gen/Phen / 517
- Conditions
- Anemia, Sickle Cell
- Keywords
- Sickle Cell Disease, Sickle Cell Anemia, DNA
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funds for study ended September 30, 2008.
- Enrolment
- 3,640 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 12 Sep 2007 (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.
Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. The purpose of this study is to collect, test, and archive blood and DNA samples from children and adults with SCD to study the role that genes play in SCD. Blood and DNA samples will be stored for use in future SCD studies.
Detailed description
SCD is an inherited blood disorder that is caused by an abnormal type of hemoglobin. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." The Comprehensive Sickle Cell Centers (CSCC) is a network of 10 centers that conduct research to improve health care and treatment options for people with SCD. The Collaborative Data Project (C-Data) is a CSCC study that is establishing a comprehensive database of children and adults with SCD who are receiving medical care at participating CSCC research centers. This study will initiate the development of a centralized laboratory that will collect, test, and archive blood and DNA samples from participants in the C-Data project for use in future SCD studies. The collection of blood and DNA samples will provide researchers with an important resource to better define the genetic diversity of SCD. In the future, genotype-phenotype correlation studies, population studies, and various other genetic studies may be conducted.
This study will enroll participants taking part in the C-Data project. For this study, participants will undergo a blood collection. The blood sample will then be sent to a lab to characterize the red blood cells and hemoglobin. DNA will be analyzed to identify genes that influence the severity of SCD. Blood and DNA will be stored for future genetic research in SCD and closely related disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adult and pediatric patients who are enrolled in the C-Data project are eligible for this study. (C-Data eligibility: All adult and pediatric patients who have been seen within the last 24 months in the hospital or clinical setting and are expected to return episodically or regularly for care at 1 of the CSCC are eligible for inclusion in the C-Data project.)
Key inclusion criteria (1 listed)
- Participating in the C-Data project
Key exclusion criteria (1 listed)
- Unable to undergo blood collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Funds for study ended September 30, 2008.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
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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.
Carolyn Hoppe, MD principal investigator
UCSF Benioff Children's Hospital Oakland
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, Sickle Cell, run by National Heart, Lung, and Blood Institute (NHLBI) at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Funds for study ended September 30, 2008.). Results are not available in the source record.
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.
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 12 Jul 2016.