Integrated Whole-Genome Analysis of Hematologic Disorders

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01108159
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Duration (Months): 47
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Diseases	Procedure: Blood Draw; Procedure: Skin Biopsy

Study Design

• Study Type: Observational
• Actual Enrollment: 35 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Integrated Whole-Genome Analysis of Hematologic Disorders Using High-Throughput Sequencing and Array Technologies
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Aug 2, 2013
• Actual Study Completion Date: Aug 2, 2013

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18 years of age or older

2. Patient meets the clinical and/or pathologic criteria for the hematologic disorder being examined.

3. Patient is willing to provide a skin biopsy and five 10 mL tubes of peripheral blood.

Exclusion Criteria:

1. Less than 18 years of age

2. Patient is not willing to provide a skin biopsy and five 10 mL tubes of peripheral blood.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: James L Zehnder, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jason D. Merker, Assistant Professor of Pathology, Stanford University
• ClinicalTrials.gov Identifier: NCT01108159
• Other Study ID Numbers: HEM0013; 1081737-100-DHAAT; SU-09092009-3820; 16329
• First Posted: Apr 21, 2010
• Last Update Posted: May 31, 2018
• Last Verified: May 1, 2018

• Additional relevant MeSH terms: Hematologic Diseases

Study Results

No Results Posted as of May 31, 2018