Screening for Hematology Branch Protocols



Status:Recruiting
Conditions:Cancer, Healthy Studies, Blood Cancer, Anemia, Hematology
Therapuetic Areas:Hematology, Oncology, Other
Healthy:No
Age Range:2 - Any
Updated:2/17/2019
Start Date:August 7, 1995
Contact:Eleftheria Koklanaris, R.N.
Email:ekoklanaris@nhlbi.nih.gov
Phone:(301) 594-4709

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Screening Protocol for Subjects Being Evaluated for Hematology Branch Protocols

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.

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.

- 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 or the subject's guardian 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
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from
Bethesda, MD
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