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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04450927
Other study ID # 200099
Secondary ID 20-H-0099
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 16, 2020
Est. completion date December 31, 2040

Study information

Verified date May 16, 2024
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 10000
Est. completion date December 31, 2040
Est. primary completion date December 31, 2040
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 120 Years
Eligibility - 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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