Research Study in Healthy Volunteers of Patients With Fanconi Anemia, Myeloproliferative Disorders, or Myeloma

NCT ID: NCT00900055

Last Updated: 2022-07-05

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

COMPLETED

Total Enrollment

213 participants

Study Classification

OBSERVATIONAL

Study Start Date

1975-06-30

Study Completion Date

2016-08-23

Brief Summary

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

RATIONALE: Analyzing tissue and blood samples from healthy volunteers or patients with Fanconi anemia, myelodysplasia, myeloproliferative disorders, or myeloma in the laboratory may help doctors learn more about the causes of blood cancers.

PURPOSE: The purpose of this study is to analyze in the laboratory blood and bone marrow cells from healthy volunteers or patients with Fanconi anemia, myeloproliferative disorders, or myeloma.

Detailed Description

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

OBJECTIVES:

* Identify the specific molecular function of the Fanconi anemia (FA) complementing gene products in hematopoietic progenitor cells from patients and normal volunteers.
* Identify functional defects in hematopoietic stromal cells, including macrophages, from patients with FA, and selected blood cancers as well as normal volunteers.

OUTLINE: Peripheral blood mononuclear leukocytes, skin fibroblasts, and marrow fibroblasts are collected for loss-of-function and gain-of-function analysis related to the Fanconi anemia complementing gene.

Conditions

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

Chronic Myeloproliferative Disorders Fanconi Anemia Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic/Myeloproliferative Neoplasms

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

microarray analysis

Intervention Type GENETIC

polyacrylamide gel electrophoresis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

protein expression analysis

Intervention Type GENETIC

reverse transcriptase-polymerase chain reaction

Intervention Type GENETIC

western blotting

Intervention Type GENETIC

chromatography

Intervention Type OTHER

high performance liquid chromatography

Intervention Type OTHER

immunoenzyme technique

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

* Diagnosis of one of the following:

* Fanconi's anemia requiring bone marrow biopsy as part of standard care (adults and children)
* Myeloproliferative disorder or myeloma (adults)
* Healthy volunteer, meeting 1 of the following criteria:

* Over 18 years of age
* Bone marrow transplant donor (children)

PATIENT CHARACTERISTICS:

* Hemoglobin \> 13 g/dL
* White blood cells (WBC) \> 4,000/mm³
* Platelet count \> 150,000/mm³
* No clinical signs or symptoms of acute or subacute infections (viral, bacterial, or fungal)
* No known blood abnormality (healthy volunteers)
* No allergies to lidocaine or xylocaine

PRIOR CONCURRENT THERAPY:

* Not specified
Minimum Eligible Age

1 Year

Maximum Eligible Age

55 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 collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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

Laura Newell

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Laura Newell, MD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

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

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, United States

Site Status

Countries

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

United States

Other Identifiers

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

P01HL048546

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OHSU-HEM-98030-L

Identifier Type: -

Identifier Source: secondary_id

IRB00000823

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.