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

NCT00900406 | Completed

• 4 other identifiers: VICC BMT 0664P30CA068485VU-VICC-BMT-0664VU-VICC-IRB-061215
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 proteomic studies using donor and recipient blood and urine samples

  End of treatment

• Tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product

  End of treatment

Study Arms (3)

Recipients of stem cells with graft versus host disease

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

Recipients of stem cells at risk of graft versus host disease

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

Donator of stem cells

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

Interventions

gene expression analysis GENETIC

blood collection

Donator of stem cells; Recipients of stem cells at risk of graft versus host disease; Recipients of stem cells with graft versus host disease

microarray analysis GENETIC

Blood collection

Donator of stem cells; Recipients of stem cells at risk of graft versus host disease; Recipients of stem cells with graft versus host disease

polymorphism analysis GENETIC

Blood collection

Donator of stem cells; Recipients of stem cells at risk of graft versus host disease; Recipients of stem cells with graft versus host disease

proteomic profiling GENETIC

Blood collection

Donator of stem cells; Recipients of stem cells at risk of graft versus host disease; Recipients of stem cells with graft versus host disease

flow cytometry OTHER

Blood collection

Donator of stem cells; Recipients of stem cells at risk of graft versus host disease; Recipients of stem cells with graft versus host disease

immunologic technique OTHER

Blood collection

Donator of stem cells; Recipients of stem cells at risk of graft versus host disease; Recipients of stem cells with graft versus host disease

laboratory biomarker analysis OTHER

Blood collection

Donator of stem cells; Recipients of stem cells at risk of graft versus host disease; Recipients of stem cells with graft versus host disease

biopsy PROCEDURE

Blood collection

Donator of stem cells; Recipients of stem cells at risk of graft versus host disease; Recipients of stem cells with graft versus host disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood collection

MeSH Terms

Conditions

Breast Neoplasms; Myeloproliferative Disorders; Gestational Trophoblastic Disease; Graft vs Host Disease; Leukemia; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Neuroblastoma; Ovarian Neoplasms; Testicular Germ Cell Tumor

Interventions

Gene Expression Profiling; Microarray Analysis; Amplified Fragment Length Polymorphism Analysis; Flow Cytometry; Immunologic Techniques; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Microchip Analytical Procedures; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Madan Jagasia, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine; Director, Outpatient Transplant Program; Section Chief, Hematology and Stem Cell Transplant;

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: January 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 6, 2012

Record last verified: 2012-11

Locations

US (3)