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

Completed

• Conditions: Gestational Trophoblastic Tumor; Ovarian Cancer; Testicular Germ Cell Tumor; Breast Cancer; Leukemia; Myelodysplastic Syndromes; Neuroblastoma; Chronic Myeloproliferative Disorders; Graft Versus Host Disease; Lymphoma
• Interventions: Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: polymorphism analysis; Genetic: proteomic profiling; Other: flow cytometry; Other: immunologic technique; Other: laboratory biomarker analysis; Procedure: biopsy

• Registration Number: NCT00900406
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-04
• Last Update Posted: 2012-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recipients of stem cells at risk of graft versus host disease	gene expression analysis	-
Recipients of stem cells at risk of graft versus host disease	microarray analysis	-
Recipients of stem cells at risk of graft versus host disease	proteomic profiling	-
Recipients of stem cells at risk of graft versus host disease	laboratory biomarker analysis	-
Donator of stem cells	immunologic technique	-
Recipients of stem cells with graft versus host disease	gene expression analysis	-
Recipients of stem cells with graft versus host disease	polymorphism analysis	-
Recipients of stem cells at risk of graft versus host disease	flow cytometry	-
Recipients of stem cells with graft versus host disease	proteomic profiling	-
Recipients of stem cells with graft versus host disease	immunologic technique	-
Recipients of stem cells with graft versus host disease	laboratory biomarker analysis	-
Recipients of stem cells with graft versus host disease	biopsy	-
Recipients of stem cells at risk of graft versus host disease	polymorphism analysis	-
Donator of stem cells	microarray analysis	-
Donator of stem cells	flow cytometry	-
Donator of stem cells	laboratory biomarker analysis	-
Recipients of stem cells with graft versus host disease	flow cytometry	-
Recipients of stem cells at risk of graft versus host disease	immunologic technique	-
Donator of stem cells	gene expression analysis	-
Recipients of stem cells with graft versus host disease	microarray analysis	-
Recipients of stem cells at risk of graft versus host disease	biopsy	-
Donator of stem cells	polymorphism analysis	-
Donator of stem cells	proteomic profiling	-
Donator of stem cells	biopsy	-

Primary Outcome Measures

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

Trial Locations

Locations (3)

Vanderbilt-Ingram Cancer Center at Franklin; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States