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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | September 15, 2009 | ||||||||
| Start Date ICMJE | December 1996 | ||||||||
| Estimated Primary Completion Date | October 2001 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
To evaluate the feasibility of using G-CSF mobilized donor blood to transplant a predetermined dose of stem cells and T lymphocytes to recipients with hematologic malignacies. | ||||||||
| Change History | Complete list of historical versions of study NCT00001620 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Screening for Hematology Branch Protocols | ||||||||
| Official Title ICMJE | Screening Protocol for Subjects Being Evaluated for Hematology Branch Protocols | ||||||||
| 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. |
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| 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 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 99999999 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | October 2001 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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. 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. |
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| Gender | Both | ||||||||
| Ages | 2 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001620 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 970041, 97-H-0041 | ||||||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | October 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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