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Screening Protocol for Subjects Being Evaluated for Hematology Branch Protocols


N/A
2 Years
N/A
Open (Enrolling)
Both
Anemia, Hematologic Neoplasm, Neutropenia, Pancytopenia, Thrombocytopenia

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Trial Information

Screening Protocol for Subjects Being Evaluated for Hematology Branch Protocols


This protocol is designed for screening of subjects before a decision can be made as to
their eligibility for one of the active Hematology Branch 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 Hematology Branch
tissue procurement or investigative therapy protocols.

Primary endpoint is the results of clinical, imaging and laboratory assessments.

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 Hematology Branch 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 Hematology Branch 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 Hematology Branch 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.

Weight greater than 12 kg. (Healthy Volunteer 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 inelibible.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Cynthia E Dunbar, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)

Authority:

United States: Federal Government

Study ID:

970041

NCT ID:

NCT00001620

Start Date:

December 1996

Completion Date:

Related Keywords:

  • Anemia
  • Hematologic Neoplasm
  • Neutropenia
  • Pancytopenia
  • Thrombocytopenia
  • Hematopoiesis
  • Thrombocytopenia
  • Anemia
  • Neutropenia
  • Dysplasia
  • Cytopenia
  • Hematologic Malignancy
  • Anemia
  • Neoplasms
  • Neutropenia
  • Pancytopenia
  • Thrombocytopenia
  • Hematologic Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892