- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01556828
Analysis of Cutaneous and Hematologic Disorders by High-Throughput Nucleic Acid Sequencing
June 22, 2016 updated by: Stanford University
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.
Study Overview
Status
Terminated
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University, School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of mutations
Time Frame: 2 years
|
Identify mutations, changes in DNA copy number, structural rearrangements, or altered coding and non-coding RNA expression
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul Khavari, MD, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
March 14, 2012
First Submitted That Met QC Criteria
March 15, 2012
First Posted (Estimate)
March 16, 2012
Study Record Updates
Last Update Posted (Estimate)
June 24, 2016
Last Update Submitted That Met QC Criteria
June 22, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Bacterial Infections and Mycoses
- Lymphoma, T-Cell
- Lymphoma
- Mycoses
- Hematologic Diseases
- Skin Diseases
- Lymphoma, T-Cell, Cutaneous
- Mycosis Fungoides
Other Study ID Numbers
- LYMNHL0091
- SU-03142012-9329 (Other Identifier: Stanford University)
- 21750 (Stanford IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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