Screening for Hematology Branch Protocols

NCT ID: NCT00001620

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hematologic Disease and Disorders Donors Healthy Volunteer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Thrombocytopenia Anemia Neutropenia Dysplasia Hematopoiesis Cytopenia Hematologic Malignancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subjects undergoing screening

Adults and children being screened for an active NHLBI protocol

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Georg Aue, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Heart, Lung, and Blood Institute (NHLBI)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Balakrishna J, Basumallik N, Matulonis R, Scott D, Salem D, Jasper G, Wiestner A, Stetler-Stevenson M, Marti G, Sun C, Yuan CM. Intensity of antigen expression reflects IGHV mutational status and Dohner-defined prognostic categories in chronic lymphocytic leukemia, monoclonal B-cell lymphocytosis, and small lymphocytic lymphoma. Leuk Lymphoma. 2021 Aug;62(8):1828-1839. doi: 10.1080/10428194.2021.1894641. Epub 2021 Mar 18.

Reference Type DERIVED
PMID: 33734005 (View on PubMed)

Wu Z, Gao S, Diamond C, Kajigaya S, Chen J, Shi R, Palmer C, Hsu AP, Calvo KR, Hickstein DD, Holland SM, Young NS. Sequencing of RNA in single cells reveals a distinct transcriptome signature of hematopoiesis in GATA2 deficiency. Blood Adv. 2020 Jun 23;4(12):2656-2670. doi: 10.1182/bloodadvances.2019001352.

Reference Type DERIVED
PMID: 32556286 (View on PubMed)

Giudice V, Wu Z, Kajigaya S, Fernandez Ibanez MDP, Rios O, Cheung F, Ito S, Young NS. Circulating S100A8 and S100A9 protein levels in plasma of patients with acquired aplastic anemia and myelodysplastic syndromes. Cytokine. 2019 Jan;113:462-465. doi: 10.1016/j.cyto.2018.06.025. Epub 2018 Jun 27.

Reference Type DERIVED
PMID: 29958797 (View on PubMed)

Giudice V, Banaszak LG, Gutierrez-Rodrigues F, Kajigaya S, Panjwani R, Ibanez MDPF, Rios O, Bleck CK, Stempinski ES, Raffo DQ, Townsley DM, Young NS. Circulating exosomal microRNAs in acquired aplastic anemia and myelodysplastic syndromes. Haematologica. 2018 Jul;103(7):1150-1159. doi: 10.3324/haematol.2017.182824. Epub 2018 Apr 19.

Reference Type DERIVED
PMID: 29674506 (View on PubMed)

Giudice V, Feng X, Lin Z, Hu W, Zhang F, Qiao W, Ibanez MDPF, Rios O, Young NS. Deep sequencing and flow cytometric characterization of expanded effector memory CD8+CD57+ T cells frequently reveals T-cell receptor Vbeta oligoclonality and CDR3 homology in acquired aplastic anemia. Haematologica. 2018 May;103(5):759-769. doi: 10.3324/haematol.2017.176701. Epub 2018 Feb 1.

Reference Type DERIVED
PMID: 29419434 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

970041

Identifier Type: -

Identifier Source: org_study_id

97-H-0041

Identifier Type: -

Identifier Source: secondary_id