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Integrated Whole-Genome Analysis of Hematologic Disorders

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ClinicalTrials.gov Identifier: NCT01108159
Recruitment Status : Recruiting
First Posted : April 21, 2010
Last Update Posted : November 9, 2016
Information provided by (Responsible Party):
Stanford University

Brief Summary:
We will use new technologies to look at the DNA, RNA, proteins, and metabolites in the disease-containing blood, bone marrow, or tissue and normal cells from the skin. Our goal is to analyze all of the genes in the diseased and normal skin sample. By comparing the results of the diseased sample and normal skin cells and the results of the two types of genetic information (DNA and RNA), we should be able to identify genetic changes that are important for the initiation, progression, or treatment response of that particular disorder.

Condition or disease Intervention/treatment
Hematologic Diseases Procedure: Blood Draw Procedure: Skin Biopsy

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integrated Whole-Genome Analysis of Hematologic Disorders Using High-Throughput Sequencing and Array Technologies
Study Start Date : September 2009
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders
U.S. FDA Resources

Primary Outcome Measures :
  1. to identify mutations, changes in DNA copy number, structural rearrangements, or altered coding and non-coding RNA expression [ Time Frame: sample collection at time of routine visit ]

Biospecimen Retention:   Samples With DNA
blood, bone marrow, skin biopsy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
participants with hematologic disorders

Inclusion Criteria:

  1. 18 years of age or older
  2. Patient meets the clinical and/or pathologic criteria for the hematologic disorder being examined.
  3. Patient is willing to provide a skin biopsy and five 10 mL tubes of peripheral blood.

Exclusion Criteria:

  1. Less than 18 years of age
  2. Patient is not willing to provide a skin biopsy and five 10 mL tubes of peripheral blood.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108159

Contact: Jason D Merker (650) 922-1885 jdmerker@stanford.edu

United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Jason D Merker    650-922-1885    jdmerker@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: James L Zehnder         
Sub-Investigator: Scott Boyd         
Sub-Investigator: Athena M. Cherry         
Sub-Investigator: Andrew Fire         
Sub-Investigator: Jason Robert Gotlib         
Sub-Investigator: Eleanor L. Marshall         
Sub-Investigator: Jason Merker         
Sub-Investigator: Stephen Tracy Oh         
Sponsors and Collaborators
Stanford University
Principal Investigator: James L Zehnder Stanford University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01108159     History of Changes
Other Study ID Numbers: HEM0013
SU-09092009-3820 ( Other Identifier: Stanford University )
16329 ( Other Identifier: Stanford IRB )
First Posted: April 21, 2010    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hematologic Diseases