NCT01108159

Brief Summary

We will use new technologies to look at the DNA, RNA, proteins, and metabolites in the disease-containing blood, bone marrow, or tissue and normal cells from the skin. Our goal is to analyze all of the genes in the diseased and normal skin sample. By comparing the results of the diseased sample and normal skin cells and the results of the two types of genetic information (DNA and RNA), we should be able to identify genetic changes that are important for the initiation, progression, or treatment response of that particular disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2013

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

3.9 years

First QC Date

April 19, 2010

Last Update Submit

May 29, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

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

    sample collection at time of routine visit

Interventions

Blood DrawPROCEDURE
Skin BiopsyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

participants with hematologic disorders

You may qualify if:

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

You may not qualify if:

  • Less than 18 years of age
  • Patient is not willing to provide a skin biopsy and five 10 mL tubes of peripheral blood.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Merker JD, Roskin KM, Ng D, Pan C, Fisk DG, King JJ, Hoh R, Stadler M, Okumoto LM, Abidi P, Hewitt R, Jones CD, Gojenola L, Clark MJ, Zhang B, Cherry AM, George TI, Snyder M, Boyd SD, Zehnder JL, Fire AZ, Gotlib J. Comprehensive whole-genome sequencing of an early-stage primary myelofibrosis patient defines low mutational burden and non-recurrent candidate genes. Haematologica. 2013 Nov;98(11):1689-96. doi: 10.3324/haematol.2013.092379. Epub 2013 Jul 19.

Biospecimen

Retention: SAMPLES WITH DNA

blood, bone marrow, skin biopsy

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • James L Zehnder

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pathology

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 21, 2010

Study Start

September 1, 2009

Primary Completion

August 2, 2013

Study Completion

August 2, 2013

Last Updated

May 31, 2018

Record last verified: 2018-05

Locations