Screening for Hematology Branch Protocols

This study is currently recruiting participants.
Verified May 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001620
First received: November 3, 1999
Last updated: March 14, 2014
Last verified: May 2013
  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
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):

Estimated Enrollment: 99999999
Study Start Date: December 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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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 inelibible.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001620

Contacts
Contact: Cynthia E Dunbar, M.D. (301) 402-1363 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
Investigators
Principal Investigator: Cynthia E Dunbar, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00001620     History of Changes
Other Study ID Numbers: 970041, 97-H-0041
Study First Received: November 3, 1999
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Hematopoiesis
Thrombocytopenia
Anemia
Neutropenia
Dysplasia
Cytopenia
Hematologic Malignancy

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

ClinicalTrials.gov processed this record on April 17, 2014