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Evaluation, Treatment, and Training for Patients With Blood Disorders

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ClinicalTrials.gov Identifier: NCT00001397
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information
First Submitted Date November 3, 1999
First Posted Date November 4, 1999
Last Update Posted Date April 11, 2019
Actual Study Start Date November 8, 1993
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: September 28, 2018)
To provide a mechanism for the evaluation, follow-up, and standard hematological care of patients by the Hematology Branch [ Time Frame: 20 years ]
To provide a mechanism for the evaluation, follow-up, and standard hematological care of patients by the Hematology Branch
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00001397 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation, Treatment, and Training for Patients With Blood Disorders
Official Title Evaluation, Treatment and Training Protocol for Patients With Bone Marrow Failure States, Isolated or Multilineage Cytopenias, Metastatic Solid Tumors, or Hematologic Malignancies
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.

Detailed Description This protocol is designed to allow the evaluation, follow up, and standard medical care of patients (and when appropriate, their stem cell donor) with bone marrow failure states, cytopenias, metastatic solid tumors, or hematologic malignancies not currently entered on an active NHLBI protocol or not being screened for an active NHLBI research protocol. Its purpose is to allow investigation into the hematologic problems of these patients for the primary purpose of teaching and furthering general hematologic knowledge. The ability to evaluate and treat patients with a wide variety of hematologic disease is critical to maintaining our accreditation as a hematology fellowship program and training our fellows to be competent hematologists, as well as for keeping all staff, including senior staff, up-to-date and familiar with the evaluation and treatment of patients with a wide spectrum of hematologic disease. It also allows the NHLBI investigators to evaluate patients referred with rare or as yet undiagnosed hematologic problems, both potentially benefiting the patient and stimulating new research directions for the NHLBI in the future. Periodic follow-up and treatment of patients previously entered on NHLBI protocols in order to monitor the long-term course of the underlying hematologic state and the consequences of experimental treatments is also required for fellowship training, and for maintenance of good referral relationships with patients and their physicians.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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.@@@
Condition Hematologic Diseases
Intervention Not Provided
Study Groups/Cohorts 1
treated according to the guidelines of standard medical evaluation and care. No investigational treatments or procedures will be administered on this protocol.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 23, 2009)
99999999
Original Enrollment
 (submitted: June 23, 2005)
9999999
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Georg Aue, M.D. (301) 451-7141 aueg@nhlbi.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00001397
Other Study ID Numbers 940010
94-H-0010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators
Principal Investigator: Georg Aue, M.D. National Heart, Lung, and Blood Institute (NHLBI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date December 28, 2018