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Establishing a Database of People With Sickle Cell Disease (Comprehensive Sickle Cell Centers Collaborative Data Project [C-Data]) (C-Data)

2016年7月11日更新者：National Heart, Lung, and Blood Institute (NHLBI)

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.

研究概览

地位

终止

条件

贫血，镰状细胞

详细说明

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.

研究类型

观察性的

注册 (实际的)

3640

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- California
  - Oakland、California、美国、94609
    - Children's Hospital of Oakland
  - San Francisco、California、美国、94134
    - University of California, San Francisco
- Florida
  - Miami、Florida、美国、33136
    - University of Miami
- Kentucky
  - Louisville、Kentucky、美国、40202
    - Kosair Children's Hospital
- Massachusetts
  - Boston、Massachusetts、美国、02118
    - Boston Medical Center
  - Boston、Massachusetts、美国、02115
    - Brigham & Women's Hospital
  - Boston、Massachusetts、美国、02115
    - Children's Hospital of Boston
- New York
  - Bronx、New York、美国、10463
    - Montefiore Medical Center
- North Carolina
  - Chapel Hill、North Carolina、美国、27599
    - University of North Carolina-Chapel Hill
  - Durham、North Carolina、美国、27710
    - Duke University
- Ohio
  - Cincinnati、Ohio、美国、45229
    - Cincinnati Children's Hospital
- Oklahoma
  - Oklahoma City、Oklahoma、美国、73104
    - University of Oklahoma Health Sciences
- Pennsylvania
  - Philadelphia、Pennsylvania、美国、19104
    - Children's Hospital of Philadelphia
  - Philadelphia、Pennsylvania、美国、19107
    - Thomas Jefferson University Hospital
  - Philadelphia、Pennsylvania、美国、19134
    - St. Christopher's Hospital for Children
- Tennessee
  - Memphis、Tennessee、美国、38105
    - Saint Jude Children's Hospital
- Texas
  - Dallas、Texas、美国、75235
    - Children's Medical Center of Dallas
  - Dallas、Texas、美国、75235
    - University of Texas Southwestern and Parkland
  - Galveston、Texas、美国、77555
    - University of Texas at Galveston

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人
年长者

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

Inclusion Criteria:

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

Exclusion Criteria:

Deceased CSCC patient
Inactive CSCC patient

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Heart, Lung, and Blood Institute (NHLBI)

调查人员

首席研究员：Susi Lieff, PhD、Statistics and Data Management Center (SDMC) (RhoFed)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年3月1日

初级完成 (实际的)

2008年9月1日

研究完成 (实际的)

2008年9月1日

研究注册日期

首次提交

2007年9月12日

首先提交符合 QC 标准的