Collecting and Storing Tissue and DNA Samples From Patients Undergoing a Donor Stem Cell Transplant

November 4, 2012 updated by: Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center

Tissue Bank for Studies Related to Graft-Versus-Host Disease (GVHD)

RATIONALE: Collecting and storing samples of blood, urine, and tissue from patients undergoing a donor stem cell transplant to test in the laboratory may help the study of graft-versus-host disease in the future.

PURPOSE: This research study is collecting and storing tissue and DNA samples from patients undergoing a donor stem cell transplant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To establish a DNA bank from donor and recipient (prior to transplant) peripheral blood for SNP studies.
  • To establish a tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples.
  • To establish a tissue bank for proteomic studies using donor and recipient blood and urine samples.
  • To establish a tissue bank for various studies using biopsy specimens.
  • To establish a tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product.

OUTLINE: Peripheral blood samples are collected from donors prior to stem cell mobilization and from patients prior to starting preparative regimen. Samples are studied by single nucleotide polymorphism (SNP) analysis, SNP array, proteomic analysis, gene expression, and other immunological laboratory methods. Blood, urine, and tissue samples are preserved for future studies. Extra skin biopsies and gastrointestinal biopsies are performed at diagnosis of graft-vs-host disease and preserved in a tissue bank for flow cytometric studies.

Study Type

Observational

Enrollment (Actual)

190

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

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center - Cool Springs
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center at Franklin

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

People who have received a stem cell transplant and are being treated for graft versus host disease or are at risk of graft versus host disease.

Description

DISEASE CHARACTERISTICS:

  • Approved for allogeneic stem cell transplantation

  • Sample of the stem cells from donor must meet 1 of the following criteria:

    • Total peripheral blood stem cell dose > 5 X10^6 CD34+ cells/kg
    • Marrow cell dose > 3 X 10^8 nucleated cells/kg

PATIENT CHARACTERISTICS:

  • Platelet count > 50,000/mm³ (for patients undergoing endoscopic biopsies)
  • INR < 1.5 (for patients undergoing endoscopic biopsies)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Recipients of stem cells with graft versus host disease
Genetic: gene expression analysis
blood collection
Genetic: microarray analysis
Blood collection
Genetic: polymorphism analysis
Blood collection
Genetic: proteomic profiling
Blood collection
Other: flow cytometry
Blood collection
Other: immunologic technique
Blood collection
Other: laboratory biomarker analysis
Blood collection
Procedure: biopsy
Blood collection
Recipients of stem cells at risk of graft versus host disease
Genetic: gene expression analysis
blood collection
Genetic: microarray analysis
Blood collection
Genetic: polymorphism analysis
Blood collection
Genetic: proteomic profiling
Blood collection
Other: flow cytometry
Blood collection
Other: immunologic technique
Blood collection
Other: laboratory biomarker analysis
Blood collection
Procedure: biopsy
Blood collection
Donator of stem cells
Genetic: gene expression analysis
blood collection
Genetic: microarray analysis
Blood collection
Genetic: polymorphism analysis
Blood collection
Genetic: proteomic profiling
Blood collection
Other: flow cytometry
Blood collection
Other: immunologic technique
Blood collection
Other: laboratory biomarker analysis
Blood collection
Procedure: biopsy
Blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DNA bank from donor and recipient (prior to transplant) peripheral blood for single nucleotide polymorphism studies
Time Frame: Completion of transplant
Completion of transplant
Tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples
Time Frame: End of treatment
End of treatment
Tissue bank for proteomic studies using donor and recipient blood and urine samples
Time Frame: End of treatment
End of treatment
Tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product
Time Frame: End of treatment
End of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center

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

January 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

November 6, 2012

Last Update Submitted That Met QC Criteria

November 4, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC BMT 0664
  • P30CA068485 (U.S. NIH Grant/Contract)
  • VU-VICC-BMT-0664
  • VU-VICC-IRB-061215

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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