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

• Sponsor: Vanderbilt-Ingram Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00900406
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 190
• Locations: 3
• Duration (Months): 37.9
• Patients Per Site: 63.3
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Chronic Myeloproliferative Disorders; Gestational Trophoblastic Tumor; Graft Versus Host Disease; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Neuroblastoma; Ovarian Cancer; Testicular Germ Cell Tumor	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

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 Design

• Study Type: Observational
• Actual Enrollment: 190 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Tissue Bank for Studies Related to Graft-Versus-Host Disease (GVHD)
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. DNA bank from donor and recipient (prior to transplant) peripheral blood for single nucleotide polymorphism studies [Completion of transplant]

2. Tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples [End of treatment]

3. Tissue bank for proteomic studies using donor and recipient blood and urine samples [End of treatment]

4. Tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product [End of treatment]

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee	United States	37064
2	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee	United States	37064
3	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838

Sponsors and Collaborators

• Vanderbilt-Ingram Cancer Center
• National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Madan Jagasia, MD, Associate Professor of Medicine; Director, Outpatient Transplant Program; Section Chief, Hematology and Stem Cell Transplant;, Vanderbilt-Ingram Cancer Center
• ClinicalTrials.gov Identifier: NCT00900406
• Other Study ID Numbers: VICC BMT 0664; P30CA068485; VU-VICC-BMT-0664; VU-VICC-IRB-061215
• First Posted: May 12, 2009
• Last Update Posted: Nov 6, 2012
• Last Verified: Nov 1, 2012

• Additional relevant MeSH terms: Neoplasms; Multiple Myeloma; Neuroblastoma; Neoplasms, Plasma Cell; Plasmacytoma; Trophoblastic Neoplasms; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Graft vs Host Disease

Study Results

No Results Posted as of Nov 6, 2012