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

This study is currently recruiting participants.
Verified April 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01556828
First received: March 14, 2012
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Cutaneous Lymphoma
Other Skin Disorders
Mycosis Fungoides
Cutaneous T-cell Lymphoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Analysis of Cutaneous and Hematologic Disorders by High-Throughput Nucleic Acid Sequencing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Number of mutations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556828

Contacts
Contact: Alexander Ungewickell 650-723-6661 ungewica@stanford.edu

Locations
United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Sub-Investigator: Youn Kim, MD            
Sub-Investigator: Carolyn Lee, MD            
Sub-Investigator: Bruno C Medeiros, MD            
Sub-Investigator: Alexander Ungewickell, MD            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Paul Khavari, MD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01556828     History of Changes
Other Study ID Numbers: LYMNHL0091, SU-03142012-9329, 21750
Study First Received: March 14, 2012
Last Updated: April 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hematologic Diseases
Lymphoma
Mycoses
Mycosis Fungoides
Skin Diseases
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
 Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 19, 2013