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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hematologic Diseases; Wide Spectrum of 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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 120 years (Child, Adult, Older Adult)
• 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

Description

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To add value to the NHLBI training program	To add value to the NHLBI training program by providing consult, treatment, diagnostic tests, and medical follow-up of participants	20 years

Collaborators and Investigators

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Georg Aue, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Estimated): December 31, 2040
• Study Completion (Estimated): December 31, 2040

Study Registration Dates

• First Submitted: June 27, 2020
• First Submitted That Met QC Criteria: June 27, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Estimated): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 20, 2024
• Last Verified: April 18, 2024

More Information

Terms related to this study

• Keywords: Natural History; Oncology; Hematology; Pulmonary; Cardiology; Repository
• Additional Relevant MeSH Terms: Hematologic Diseases
• Other Study ID Numbers: 200099; 20-H-0099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No