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Screening for Hematology Branch Protocols

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ClinicalTrials.gov Identifier: NCT00001620
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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.


Condition or disease
Hematologic Disease and Disorders Donors Healthy Volunteer

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.


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Study Type : Observational
Estimated Enrollment : 9999 participants
Observational Model: Other
Time Perspective: Other
Official Title: Screening Protocol for Subjects Being Evaluated for Hematology Branch Protocols
Actual Study Start Date : August 7, 1995

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Primary endpoint is the results of clinical, imaging and laboratory assessments. [ Time Frame: ongoing ]
    Results of clinical, imaging and laboratory assessments



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects referred for active National Heart, Lung, and Blood Institute (NHLBI) research protocols, donors and healthy volunteers@@@@@@
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 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001620


Contacts
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Contact: Eleftheria Koklanaris, R.N. (301) 594-4709 ekoklanaris@nhlbi.nih.gov
Contact: Georg Aue, M.D. (301) 451-7141 aueg@nhlbi.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Georg Aue, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00001620     History of Changes
Other Study ID Numbers: 970041
97-H-0041
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: February 6, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Thrombocytopenia
Anemia
Neutropenia
Dysplasia
Hematopoiesis
Cytopenia
Hematologic Malignancy

Additional relevant MeSH terms:
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Hematologic Diseases
Disease
Pathologic Processes