Wide Spectrum of DiseasesNCT04450927
Data Collection of Standard Care and Evaluation of NHLBI Patients and Donors
An observational study of Wide Spectrum of Diseases and Hematologic Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Wide Spectrum of Diseases, Hematologic Diseases
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2020to 31 Dec 2040
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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:
- 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.
- 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.
- Age more than or equal to 2 and weight > 12 kg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Wide Spectrum of Diseases, Hematologic Diseases
- Keywords
- Repository, Hematology, Cardiology, Pulmonary, Oncology, Natural History
- Medical subject headings
- Hematologic Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 years
Secondary outcomes (1)
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
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start16 Jun 2020
- Primary completion31 Dec 2040 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wide Spectrum of DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David J Young, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450927
- Sponsor's protocol ID
- 200099
- Other IDs
- 20-H-0099
- Status last verified
- 19 Oct 2026
- First submitted
- 27 Jun 2020
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided