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

NCT01556828 | Terminated DMC

• 3 other identifiers: LYMNHL0091SU-03142012-932921750
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of mutations

  Identify mutations, changes in DNA copy number, structural rearrangements, or altered coding and non-coding RNA expression

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Less than 18 years of age

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood tissue

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Paul Khavari, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 16, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 24, 2016

Record last verified: 2016-06

Locations

US (1)