Screening for Hematology Branch Protocols

Healthy Volunteer Clinical Trial

Official title:

Screening Protocol for Subjects Being Evaluated for National Heart, Lung and Blood Institute (NHLBI) Protocols

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00001620
• Other study ID #: 970041
• Secondary ID: 97-H-0041
• Status: Enrolling by invitation
• Start date: December 31, 1996

Study information

• Verified date: May 16, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 100 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Disease
• Donors
• Healthy Volunteer
• Hematologic Disease and Disorders
• Hematologic Diseases

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint is the results of clinical, imaging and laboratory assessments.	Results of clinical, imaging and laboratory assessments	ongoing

External Links

•   NIH Clinical Center Detailed Web Page