Targeted Single Nucleotide Polymorphisms (SNPs) to Classify Subtypes of Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Transplant.
N/A
N/A
Both
Cancer
Trial Information
Targeted Single Nucleotide Polymorphisms (SNPs) to Classify Subtypes of Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Transplant.
OBJECTIVES:
- To determine and define the biological basis of different subtypes of chronic
graft-vs-host disease using a targeted single nucleotide polymorphisms approach in
patients who have undergone allogeneic stem cell transplantation.
OUTLINE: Two important aspects of the methodologies that will be employed for the analysis
of SNPs associated with GVHD are throughput efficiency to be able to perform the assays on a
reasonable number of samples as well as having the ability to add or remove SNPs to the
assay panel. While a genome-wide association study to identify variants associated with GVHD
would offer an unbiased approach, our patient cohort size would not allow significant
statistical power in the study. Therefore, a more targeted approach using two established
technologies is proposed.
The Sequenome assay uses the unique combination of a single-base primer extension assay
incorporating one of four modified nucleotides. The four modified nucleotides each have a
unique mass that allows them to be distinguished from one another using mass spectrometry.
Each SNP is determined analyzing the primer extension product from a PCR amplicon that
surrounds the SNP of interest. The development of each assay involves designing flanking PCR
primers and an internal extension assay using web-based software provided by Sequenome. The
assays can be designed to analyze up to 30 SNPs in a single reaction, providing a
customizable, efficient and high-throughput assay for SNPs of interest.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Underwent prior matched related or unrelated allogeneic stem cell transplantation
(SCT)
- Presence OR absence of chronic graft-vs-host disease after day 100 and alive
after day 180 post-transplantation
- No T-cell depleted SCT, cord blood transplantation, mismatched allogeneic
transplantation, or autologous transplantation
- Available recipient and donor DNA (samples collected from the Vanderbilt University
or the Fred Hutchinson Cancer Center tissue bank)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Retrospective
Outcome Measure:
To study the SNP profiles of a select group of candidate non-HLA genes among various cGVHD subtypes. Patients will be stratified as having classic cGVHD vs. non-classic GVHD for initial analyses.
Outcome Time Frame:
Upon data collection of final patient
Safety Issue:
No
Principal Investigator
Madan Jagasia, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Federal Government
Study ID:
VICC BMT 0867
NCT ID:
NCT00957736
Start Date:
November 2008
Completion Date:
December 2008
Related Keywords:
- Cancer
- graft versus host disease
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult Hodgkin lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III small lymphocytic lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult Hodgkin lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent childhood large cell lymphoma
- recurrent childhood lymphoblastic lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- noncontiguous (NC) stage II adult Burkitt lymphoma
- NC stage II adult diffuse large cell lymphoma
- NC stage II adult diffuse mixed cell lymphoma
- NC stage II adult diffuse small cleaved cell lymphoma
- NC stage II adult immunoblastic large cell lymphoma
- NC stage II adult lymphoblastic lymphoma
- NC stage II grade 1 follicular lymphoma
- NC stage II grade 2 follicular lymphoma
- NC stage II grade 3 follicular lymphoma
- NC stage II mantle cell lymphoma
- NC stage II marginal zone lymphoma
- NC stage II small lymphocytic lymphoma
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- adult acute myeloid leukemia in remission
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- atypical chronic myeloid leukemia, BCR-ABL negative
- blastic phase chronic myelogenous leukemia
- childhood acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- childhood chronic myelogenous leukemia
- chronic myelomonocytic leukemia
- chronic phase chronic myelogenous leukemia
- juvenile myelomonocytic leukemia
- recurrent adult acute lymphoblastic leukemia
- recurrent adult acute myeloid leukemia
- recurrent childhood acute lymphoblastic leukemia
- recurrent childhood acute myeloid leukemia
- refractory chronic lymphocytic leukemia
- refractory hairy cell leukemia
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- childhood myelodysplastic syndromes
- chronic eosinophilic leukemia
- primary myelofibrosis
- chronic neutrophilic leukemia
- de novo myelodysplastic syndromes
- disseminated neuroblastoma
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- poor prognosis metastatic gestational trophoblastic tumor
- previously treated childhood rhabdomyosarcoma
- previously treated myelodysplastic syndromes
- recurrent Wilms tumor and other childhood kidney tumors
- recurrent childhood rhabdomyosarcoma
- recurrent neuroblastoma
- recurrent ovarian epithelial cancer
- recurrent ovarian germ cell tumor
- recurrent malignant testicular germ cell tumor
- secondary myelodysplastic syndromes
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- stage II ovarian epithelial cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- stage III malignant testicular germ cell tumor
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- refractory multiple myeloma
- Graft vs Host Disease
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville, Tennessee 37064 |
| Vanderbilt-Ingram Cancer Center at Franklin | Nashville, Tennessee 37064 |
