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Data Collection of Standard Care and Evaluation of NHLBI Patients and Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04450927
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:

Background:

Researchers seek ways to study people s medical problems in order to teach and further general knowledge. The ability to assess and treat people with a wide range of diseases is critical to training people to be good doctors. It is also needed to keep medical staff up to date. In this study, researchers want to study the course of some illnesses to learn more about them. To do this, they will collect and review people s medical records. In some cases, they may also provide treatment.

Objective:

To collect data that may be used to help researchers create ideas for future research.

Eligibility:

People age 2 and older who have or are suspected to have a medical condition for which they have been referred to NIH s National Heart, Lung, and Blood Institute, as well as stem cell donors

Design:

Participants may be screened with a review of the following:

Medical records

Scans and images

Other existing samples and reports.

Participants medical data will be collected from the standard care they receive. This includes their routine blood and urine tests, X-rays and scans, and other tests to diagnose or follow their medical condition. Data will also be collected from the treatments they may receive. For stem cell donors, data from apheresis procedures will be collected. Demographic data will also be collected.

All of the data will be kept in the medical records or on secure network drives.

Some participants may need to be treated for their medical condition. If so, they will sign a separate consent form for that treatment.

Participation lasts up to 2 years.


Condition or disease
Wide Spectrum of Diseases Hematologic Diseases

Detailed Description:
This protocol is designed to provide a repository of information to allow for hypothesis generation in future research. This information will be drawn from standard medical care/procedures and follow up of patients and healthy volunteers, including transplant donors, who are not currently receiving therapy on an active NHLBI research protocol. It allows investigation into the problems of these patients for the purpose of teaching and furthering general knowledge. The ability to evaluate and treat patients with a wide variety of diseases is critical to maintaining our accreditation with the hematology-oncology, cardiology, and pulmonary fellowship programs and training our fellows to be competent physicians, as well as for keeping all staff, including senior staff, up-to-date and familiar with the evaluation and treatment of patients with a wide spectrum of diseases. Periodic follow-up and treatment of patients previously entered on NHLBI protocols in order to monitor the long-term course of the underlying disease and the consequences of experimental treatments is also required for fellowship training, and for maintenance of good referral relationships with patients and their physicians. This study also allows for standard apheresis procedures for transplant donors and for care of volunteers who may present with a treatable condition.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Data Collection of Standard Care and Evaluation of NHLBI Patients and Donors
Actual Study Start Date : June 16, 2020
Estimated Primary Completion Date : March 31, 2030
Estimated Study Completion Date : December 31, 2040

Group/Cohort
1
Data collection and treatment according to guidelines of standard of medical evaluation and care. No investigational treatments or procedures will be administered on this protocol.



Primary Outcome Measures :
  1. To provide a repository of information on enrolled participants to allow for hypothesis generation in future research [ Time Frame: 20 years ]
    To provide a repository of information on enrolled participants to allow for hypothesis generation in future research


Secondary Outcome Measures :
  1. To add value to the NHLBI training program [ Time Frame: 20 years ]
    To add value to the NHLBI training program by providing consult, treatment, diagnostic tests, and medicalfollow-up of participants



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 110 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All subjects 2 or older and weighing greater than 12 kg, who meet inclusion criteria will be considered for participation on this protocol at this discretion of the Principal or Associate Investigator,
Criteria
  • ELIGIBILITY:

    1. Patients (including those referred to us to rule out a disease or condition) and stem cell donors,

      may be entered on this protocol at the discretion of the Principal and/or Associate Investigators.

    2. The patient or the patient's Legally Authorized Representative is capable of informed consent and

      signs the consent form. The consent form will be signed by parents or guardians of patients under

      the age of 18.

    3. Age more than or equal to 2 and weight > 12 kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450927


Contacts
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Contact: Georg Aue, M.D. (301) 451-7141 aueg@nhlbi.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Georg Aue, M.D. National Heart, Lung, and Blood Institute (NHLBI)
Additional Information:
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT04450927    
Other Study ID Numbers: 200099
20-H-0099
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: June 30, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Repository
Hematology
Cardiology
Pulmonary
Oncology
Additional relevant MeSH terms:
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Hematologic Diseases