This trial is active, not recruiting.

Conditions chronic myeloproliferative disorders, fanconi anemia, multiple myeloma and plasma cell neoplasm, myelodysplastic/myeloproliferative neoplasms
Treatments microarray analysis, polyacrylamide gel electrophoresis, polymerase chain reaction, protein expression analysis, reverse transcriptase-polymerase chain reaction, western blotting, chromatography, high performance liquid chromatography, immunoenzyme technique
Sponsor OHSU Knight Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date June 1975
End date January 2020
Trial size 213 participants
Trial identifier NCT00900055, IRB00000823, OHSU-HEM-98030-L, P30CA069533


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Loss of function analyses
time frame: Duration of the study
Proteins binding to Fanconi anemia, complementation group C (FACC) gene-product by affinity chromatography of nuclear and whole cell lysates of normal cells
time frame: Duration of the study
Screening of proteins binding to FACC gene-product using monoclonal antibodies specific to signal transduction and cell cycle proteins
time frame: Duration of the study
Microsequencing of unique proteins
time frame: Duration of the study
Location of specific downstream block point imposed by antisense molecules using antibodies specific to signal transduction, cell cycle, or repair proteins for the FACC protein
time frame: Duration of the study
Affirmation that the block points identified are recapitulated in progenitor cells from peripheral blood
time frame: Duration of the study
Identification of functional defects in Fanconi anemia hematopoietic stromal cells
time frame: Duration of the study

Eligibility Criteria

Male or female participants from 1 year up to 55 years old.

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

Additional Information

Official title Dysregulation of Hematopoiesis in Fanconi Anemia
Principal investigator Grover C. Bagby, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by OHSU Knight Cancer Institute.