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

NCT04450927 | Enrolling By Invitation

• 2 other identifiers: 20009920-H-0099
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Wide Spectrum of Diseases; Hematologic Diseases

Keywords

Repository; Hematology; Cardiology; Pulmonary; Oncology; Natural History

Outcome Measures

Primary Outcomes (1)

• To provide a repository of information on enrolled participants to allow for hypothesis generation in future research

  To provide a repository of information on enrolled participants to allow for hypothesis generation in future research

  20 years

Secondary Outcomes (1)

• To add value to the NHLBI training program

  20 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 2 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hematologic Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Georg Aue, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2020
• First Posted: June 30, 2020
• Study Start: June 16, 2020
• Primary Completion (Estimated): December 31, 2040
• Study Completion (Estimated): December 31, 2040
• Last Updated: April 8, 2026

Record last verified: 2026-03-27

Locations

US (1)