Analysis of Cutaneous and Hematologic Disorders by High-T... | NCT01556828

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

NCT01556828

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Jun 24, 2016Estimated

Enrollment

70Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SU-03142012-9329	Other Identifier	Stanford University
21750	Other Identifier	Stanford IRB

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Mar 14, 2012

First Submission Date that Met QC Criteria

Mar 15, 2012

First Posted Date

Mar 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2016

Last Update Posted Date

Jun 24, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

70Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of mutations	Identify mutations, changes in DNA copy number, structural rearrangements, or altered coding and non-coding RNA expression	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Eligible subjects will be identified and recruited by referral from that individual's treating physician, mainly Stanford-affiliated dermatologists, oncologists, and hematologists.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul Khavari, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University, School of Medicine		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D016410	Lymphoma, T-Cell, Cutaneous
D009182	Mycosis Fungoides

Ancestor Terms

ID	Term
D016399	Lymphoma, T-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided