Screening for Hematology Branch Protocols
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00001620 |
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Recruitment Status :
Enrolling by invitation
First Posted : November 4, 1999
Last Update Posted : May 20, 2022
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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 |
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| Hematologic Disease and Disorders Donors Healthy Volunteer |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 10000 participants |
| Observational Model: | Other |
| Time Perspective: | Cross-Sectional |
| Official Title: | Screening Protocol for Subjects Being Evaluated for National Heart, Lung and Blood Institute (NHLBI) Protocols |
| Actual Study Start Date : | January 6, 1997 |
| Group/Cohort |
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Subjects undergoing screening
Adults and children being screened for an active NHLBI protocol
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- Primary endpoint is the results of clinical, imaging and laboratory assessments. [ Time Frame: ongoing ]Results of clinical, imaging and laboratory assessments
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
- 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.
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
| United States, Maryland | |
| National Institutes of Health Clinical Center | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Georg Aue, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00001620 |
| Other Study ID Numbers: |
970041 97-H-0041 |
| First Posted: | November 4, 1999 Key Record Dates |
| Last Update Posted: | May 20, 2022 |
| Last Verified: | April 14, 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Thrombocytopenia Anemia Neutropenia Dysplasia |
Hematopoiesis Cytopenia Hematologic Malignancy |
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Hematologic Diseases Disease Pathologic Processes |