Clinical trial NCT00001620: Screening for Hematology Branch Protocols
Official title: Screening Protocol for Subjects Being Evaluated for National Heart, Lung and Blood Institute (NHLBI) Protocols
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hematologic Disease and Disorders
Donors
Healthy Volunteer
Keywords: Thrombocytopenia
Anemia
Neutropenia
Dysplasia
Hematopoiesis
Cytopenia
Hematologic Malignancy
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 10000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects referred for active National Heart, Lung, and Blood Institute (NHLBI) research protocols, donors and healthy volunteers@@@@@@

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.

Eligibility 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 which 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 which the NHLBI has an active study recruiting healthy normal volunteers and he/she appears to meet preliminary eligibility as a normal volunteer.

Age greater than or equal to 2 and Weight greater than 12 kg. (Healthy Volunteer age greater than or equal to 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.

Primary outcomes:
measure: Primary endpoint is the results of clinical, imaging and laboratory assessments.
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Georg Aue, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Giudice V, Feng X, Lin Z, Hu W, Zhang F, Qiao W, Ibanez MDPF, Rios O, Young NS. Deep sequencing and flow cytometric characterization of expanded effector memory CD8+CD57+ T cells frequently reveals T-cell receptor Vbeta oligoclonality and CDR3 homology in acquired aplastic anemia. Haematologica. 2018 May;103(5):759-769. doi: 10.3324/haematol.2017.176701. Epub 2018 Feb 1.