NCT00001397

Brief Summary

This study is designed to allow the evaluation, follow-up, and medical care of patients with blood disorders not currently participating in a research study being conducted by the Hematology Branch of the National Heart, Lung and Blood Institute (NHLBI) or not being screened for participation in a study. The purpose of this study is to allow investigation into the blood disorders of patients in order to teach, learn, and gather more information about diseases of the blood. In addition, this study allows researchers the opportunity to evaluate patients referred to the Hematology Branch of the NHLBI with rare or undiagnosed diseases of the blood. This may be potentially beneficial to the patient and at the same time contribute to the development of new research ideas.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,452

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 1993

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 1993

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
20.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

26.9 years

First QC Date

November 3, 1999

Last Update Submit

October 5, 2020

Conditions

Hematologic Diseases

Keywords

HematopoiesisThrombocytopeniaAnemiaNeutropeniaDysplasiaHematologic Malignancies

Outcome Measures

Primary Outcomes (1)

  • To provide a mechanism for the evaluation, follow-up, and standard hematological care of patients by the Hematology Branch

    To provide a mechanism for the evaluation, follow-up, and standard hematological care of patients by the Hematology Branch

    20 years

Study Arms (1)

1

treated according to the guidelines of standard medical evaluation and care. No investigational treatments or procedures will be administered on this protocol.

Eligibility Criteria

Age2 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects age 2 or older and weighing greater than 12 kg, who meet entry criteria will be considered for participation on this protocol at the discretion of the Principal or Associate Investigator.

You may qualify if:

  • Patients (and when appropriate the patient's stem cell donor) may be entered on this protocol at the discretion of the Principal and/or Associate Investigators if :
  • An investigator decides that it is in the best interest of the patient/donor and the Branch for the patient to be enrolled in this protocol while awaiting a decision on eligibility for other protocols; or after enrollment on another protocol, or to allow careful evaluation of patients with unique or rare disorders of direct interest to the Branch; or with more common disorders for fellowship teaching purposes.
  • The patient or the patient's guardian is capable of informed consent and signs the consent form. The consent form will be signed by parents or guardians of patients under the age of 18.
  • Age greater than or equal to 2 and weight greater than 12 kg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 29958797DERIVED

  • 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.

    PMID: 29674506DERIVED

  • 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.

    PMID: 29419434DERIVED

Related Links

MeSH Terms

Conditions

Hematologic DiseasesThrombocytopeniaAnemiaNeutropeniaHematologic Neoplasms

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesBlood Platelet DisordersCytopeniaAgranulocytosisLeukopeniaLeukocyte DisordersNeoplasms by SiteNeoplasms

Study Officials

  • Georg Aue, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

November 8, 1993

Primary Completion

October 5, 2020

Study Completion

October 5, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

US(1)