Donors, Healthy Volunteer, Hematologic Disease and Disorders
Conditions
Keywords
Thrombocytopenia, Anemia, Neutropenia, Dysplasia, Hematopoiesis, Cytopenia, Hematologic Malignancy
Brief summary
This study allows the evaluation of subjects in order to determine their ability to safely participate in other active research studies. After subjects complete the screening process, they will be offered the opportunity to participate in an active research study, or if no appropriate studies are available information and recommendations will be provided for other treatment options....
Detailed description
This protocol is designed for screening of subjects before a decision can be made as to their eligibility for one of the active National Heart, Lung, and Blood Institute (NHLBI) research protocols. Its purpose is to allow detailed investigation into the hematologic or oncologic problems of these subjects, and the status of other organ systems that would determine their ability to safely tolerate specific aspects of active research protocols. It allows investigation as to whether a donor is HLA matched, fit to receive G-CSF, and fit to undergo apheresis and therefore eligible to participate as a donor on a bone marrow transplant protocol. It also allows the investigation as to whether subjects are eligible for participation as normal volunteer based on protocol eligibility criteria that requires generally good health status by history or physical exam findings, or laboratory assessments. After completion of this screening process, the subject will either be offered a chance to participate in an active research protocol, or if no appropriate protocol is identified, subjects with hematologic or oncologic disease will have recommendations for other treatment options relayed to the primary or referring physician. Primary objective is to determine subject eligibility for participation on NHLBI protocols. Primary endpoint is the results of clinical, imaging and laboratory assessments.
Interventions
None listed
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
2 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* INCLUSION CRITERIA: Subjects will be entered on this protocol at the time of their first visit to the NIH Clinical Center outpatient clinic or inpatient service if: The subject carries the diagnosis of a disorder for which the NHLBI has an active research protocol, and based on information received from an outside physician, he/she appears to meet at least preliminary eligibility criteria for that protocol OR The subject is a donor for a subject for whom the NHLBI has an active stem cell transplant protocol and based on information received from an outside physician, he/she appears to meet preliminary eligibility as a donor OR The subject is a normal volunteer for whom the NHLBI has an active study recruiting healthy normal volunteers and he/she appears to meet preliminary eligibility as a normal volunteer Age \>= 2 and Weight \>12 kg (healthy volunteers age \>=8) The subject, the subject's guardian (if the subject is a minor), or the subject's legally authorized representative (LAR) is capable of informed consent, and willing to sign the consent form after initial counseling by clinical staff. Separate consent forms for all interventional or surgical procedures will be obtained after explanation of the specific procedure.
Exclusion criteria
All subjects not fulfilling the inclusion criteria will be considered ineligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint is the results of clinical, imaging and laboratory assessments. | ongoing | Results of clinical, imaging and laboratory assessments |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid J Young, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Outcome results
None listed