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Screening for Hematology Branch Protocols

This study is currently recruiting participants.
Verified May 12, 2017 by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001620
First Posted: November 4, 1999
Last Update Posted: October 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
  Purpose

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
Anemia Hematologic Neoplasm Neutropenia Pancytopenia Thrombocytopenia

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: Screening Protocol for Subjects Being Evaluated for Hematology Branch Protocols

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):

Primary Outcome Measures:
  • Determine patient eligibility [ Time Frame: ongoing ]

Estimated Enrollment: 9999
Study Start Date: December 10, 1996
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.

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.

  Eligibility

Information from the National Library of Medicine

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 ineligible.

  Contacts and Locations
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
Contact: Sophia Grasmeder, R.N. (301) 827-0367 grasmeders@mail.nih.gov
Contact: Cynthia E Dunbar, M.D. (301) 496-5093 dunbarc@nhlbi.nih.gov

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Cynthia E Dunbar, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
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 Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: October 19, 2017
Last Verified: May 12, 2017

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

Additional relevant MeSH terms:
Thrombocytopenia
Neutropenia
Hematologic Neoplasms
Pancytopenia
Blood Platelet Disorders
Hematologic Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Neoplasms by Site
Neoplasms