ClinicalTrials.gg
Enrolling by invitationNCT00001620Updated Nov 9, 2026

Screening for Hematology Branch Protocols

An observational study in Hematologic Disease and Disorders, Donors and Healthy Volunteer, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Enrolling by invitation at 1 site in United States. Open to participants aged 2 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
10,000
Ages
2 Years to 100 Years
Sex
All
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Study 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....

Read the 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 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.

02

Conditions studied

  • Hematologic Disease and Disorders
  • Donors
  • Healthy Volunteer

Keywords

  • Thrombocytopenia
  • Anemia
  • Neutropenia
  • Dysplasia
  • Hematopoiesis
  • Cytopenia
  • Hematologic Malignancy
03

In context

Hematologic Diseases

609 studies on the registry are indexed under Hematologic Diseases; 108 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 250 across 127 observational studies indexed under Hematologic Diseases.

Browse Hematologic Diseases studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 71 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 51 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects referred for active National Heart, Lung, and Blood Institute (NHLBI) research protocols, donors and healthy volunteers@@@@@@

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 whom 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 whom the NHLBI has an active study recruiting healthy normal volunteers and he/she appears to meet preliminary eligibility as a normal volunteer

Age >= 2 and Weight >12 kg (healthy volunteers age >=8)

The subject, the subject's guardian (if the subject is a minor), or the subject's legally authorized representative (LAR) is capable of , 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

EXCLUSION CRITERIA:

All subjects not fulfilling the inclusion criteria will be considered ineligible.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
10,000 participants (estimated)

Groups and cohorts

  • Subjects undergoing screening

    Adults and children being screened for an active NHLBI protocol

06

What researchers measure

Primary outcomes

  1. Primary endpoint is the results of clinical, imaging and laboratory assessments.

    Results of clinical, imaging and laboratory assessments

    Time frame: ongoing

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
08

References and documents

Publications

  • 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. PubMed 33734005 ↗
  • 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. PubMed 32556286 ↗
  • 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. PubMed 29958797 ↗
  • 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. PubMed 29674506 ↗
  • 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. PubMed 29419434 ↗

Individual participant data

Plan to share: Undecided

09

Updates

8 registry updates since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: description and verification date
8 updates, last Nov 9, 2026
Show all 8 updates
  1. Nov 9, 2026
    Minor edits only
    + 1 other change: description
  2. Nov 5, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 29, 2026
    Minor edits only
    + 1 other change: description
  4. Oct 19, 2026
    Minor edits only
    + 1 other change: verification date
  5. Oct 13, 2026
    Minor edits only
    + 1 other change: description
  6. Oct 8, 2026
    Minor edits only
    + 1 other change: description
  7. Oct 2, 2026
    Minor edits only
    + 1 other change: description
  8. Sep 28, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT00001620
Responsible party
Sponsor
First posted
Nov 4, 1999
Start date
Dec 31, 1996
Last update
Nov 9, 2026

Study contacts

David J Young, M.D.
principal investigator · National Heart, Lung, and Blood Institute (NHLBI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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