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Analysis of Cutaneous and Hematologic Disorders by High-Throughput Nucleic Acid Sequencing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01556828
Recruitment Status : Terminated
First Posted : March 16, 2012
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
The goal of this study is to identify genetic changes associated with the initiation, progression, and treatment response of response of cutaneous and hematologic disorders using recently developed high-throughput sequencing technologies. The improved understanding of the genetic changes associated with cutaneous and hematologic disorders may lead to improved diagnostic, prognostic and therapeutic options for these disorders.

Condition or disease
Cutaneous Lymphoma Other Skin Disorders Mycosis Fungoides Cutaneous T-cell Lymphoma

Study Design
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Study Type : Observational
Actual Enrollment : 70 participants
Time Perspective: Prospective
Official Title: Analysis of Cutaneous and Hematologic Disorders by High-Throughput Nucleic Acid Sequencing
Study Start Date : June 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of mutations [ Time Frame: 2 years ]
    Identify mutations, changes in DNA copy number, structural rearrangements, or altered coding and non-coding RNA expression


Biospecimen Retention:   Samples With DNA
whole blood tissue

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible subjects will be identified and recruited by referral from that individual's treating physician, mainly Stanford-affiliated dermatologists, oncologists, and hematologists.
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Patient meets the clinical and/or pathologic criteria for the cutaneous or hematologic disorder being examined.
  • Patient is willing to provide skin biopsies and five 10 mL tubes of peripheral blood.

Exclusion Criteria:

- Less than 18 years of age

Contacts and Locations
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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): NCT01556828


Locations
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United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Paul Khavari, MD Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01556828    
Other Study ID Numbers: LYMNHL0091
SU-03142012-9329 ( Other Identifier: Stanford University )
21750 ( Other Identifier: Stanford IRB )
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Mycoses
Lymphoma
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Hematologic Diseases
Skin Diseases
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Bacterial Infections and Mycoses
Infections