Anemia, Sickle CellC-DataNCT00529061
Establishing a Database of People With Sickle Cell Disease (Comprehensive Sickle Cell Centers Collaborative Data Project [C-Data])
An observational study of Anemia, Sickle Cell, run by National Heart, Lung, and Blood Institute (NHLBI) at 19 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 gather medical information from children and adults with SCD and establish a database so that researchers can contact people to participate in future SCD… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anemia, Sickle Cell
- How many people
- 3,640 participants
- Where
- 19 sitesUnited States
- Study dates
- Mar 2005to 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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 one of the CSCCs, are eligible for inclusion in the C-Data project.
Who may be able to join
- Diagnosis of SCD
- Evaluated within the 24 months prior to study entry in the hospital or clinical setting
- Expected to return episodically or regularly for care at one of the CSCCs
Who cannot join
- Deceased CSCC patient
- Inactive CSCC patient
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 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 Center of Dallas
Dallas, Texas, 75235
University of Texas Southwestern and Parkland
Dallas, Texas, 75235
Duke University
Durham, North Carolina, 27710
University of Texas at Galveston
Galveston, Texas, 77555
Kosair Children's Hospital
Louisville, Kentucky, 40202
Saint Jude Children's Hospital
Memphis, Tennessee, 38105
University of Miami
Miami, Florida, 33136
Children's Hospital of Oakland
Oakland, California, 94609
University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73104
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
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 Collaborative Data Project (C-Data)
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 gather medical information from children and adults with SCD and establish a database so that researchers can contact people to participate in future SCD research studies.
Read the detailed description
SCD is an inherited blood disorder. 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. This study, the Collaborative Data Project (C-Data), will establish a comprehensive database of children and adults receiving medical care at participating CSCC research centers who are potentially eligible for inclusion in SCD clinical trials. The main purposes of this study are the following: 1) to gather medical information about a large number of people with SCD over a long period of time; 2) to identify potential participants for future SCD clinical trials; 3) to collect information about how SCD affects quality of life; and 4) to evaluate the relationship between SCD patients' characteristics and medical events.
In this study, research staff will review participants' medical records twice a year for at least 5 years. Information will be collected regarding participants' medical history, physical exams, blood tests, and demographics. Once a year, participants will take part in a short interview about their health and lifestyle. Participants will also complete quality-of-life and patient satisfaction questionnaires during the first year of the study and may complete additional questionnaires in the future. During an interview, participants will be asked general questions about their experience with SCD and more specific questions on headaches and any possible relation they may have to SCD pain. Participants may also be asked to provide a blood sample at some point during the study. CSCC researchers will analyze the information in the database and may contact participants in the future to see if they are interested in enrolling in SCD clinical trials.
- Conditions
- Anemia, Sickle Cell
- Keywords
- Sickle Cell Disease, Sickle Cell Anemia
- 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 posted14 Sep 2007 (estimated)
- Study startMar 2005
- 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
- Enrolment
- 3,640 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Susi Lieff, PhD, Principal investigator, Statistics and Data Management Center (SDMC) (RhoFed)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529061
- Sponsor's protocol ID
- 1401
- Other IDs
- U54HL070587-05
- Acronym
- C-Data
- Status last verified
- Nov 2008
- First submitted
- 12 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 Collaborative Data Project (C-Data)
- ClinicalTrials.gov ID
- NCT00529061
- Acronym / sponsor ID
- C-Data / 1401
- Conditions
- Anemia, Sickle Cell
- Keywords
- Sickle Cell Disease, Sickle Cell Anemia
- 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
- Mar 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 14 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 gather medical information from children and adults with SCD and establish a database so that researchers can contact people to participate in future SCD research studies.
Detailed description
SCD is an inherited blood disorder. 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. This study, the Collaborative Data Project (C-Data), will establish a comprehensive database of children and adults receiving medical care at participating CSCC research centers who are potentially eligible for inclusion in SCD clinical trials. The main purposes of this study are the following: 1) to gather medical information about a large number of people with SCD over a long period of time; 2) to identify potential participants for future SCD clinical trials; 3) to collect information about how SCD affects quality of life; and 4) to evaluate the relationship between SCD patients' characteristics and medical events.
In this study, research staff will review participants' medical records twice a year for at least 5 years. Information will be collected regarding participants' medical history, physical exams, blood tests, and demographics. Once a year, participants will take part in a short interview about their health and lifestyle. Participants will also complete quality-of-life and patient satisfaction questionnaires during the first year of the study and may complete additional questionnaires in the future. During an interview, participants will be asked general questions about their experience with SCD and more specific questions on headaches and any possible relation they may have to SCD pain. Participants may also be asked to provide a blood sample at some point during the study. CSCC researchers will analyze the information in the database and may contact participants in the future to see if they are interested in enrolling in SCD clinical trials.
Study design
- Observational model
- Cohort
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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 one of the CSCCs, are eligible for inclusion in the C-Data project.
Key inclusion criteria (3 listed)
- Diagnosis of SCD
- Evaluated within the 24 months prior to study entry in the hospital or clinical setting
- Expected to return episodically or regularly for care at one of the CSCCs
Key exclusion criteria (2 listed)
- Deceased CSCC patient
- Inactive CSCC patient
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.
Susi Lieff, PhD principal investigator
Statistics and Data Management Center (SDMC) (RhoFed)
19 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 19 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 3 inclusion and 2 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 19 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.