Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339963
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2006-06-19
Brief Title:
Genome Expression in Lymphoma Leukemia and Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Expression of the Genome in Lymphoid Malignancies
Status:
COMPLETED
Status Verified Date:
2024-04-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will use genomics-based technology such as DNA microarrays to more precisely diagnose subsets of lymphoma leukemia and multiple myeloma patients There have been many attempts to classify lymphoid cancers in ways that will be useful for clinical diagnosis and treatment Although broad diagnostic categories have been reliably defined patients within each category have distinct clinical courses suggesting that these classifications could be further divided into molecular genetic subtypes For example 40 percent of patients with diffuse large B-cell lymphoma achieve long-term disease remissions following combination chemotherapy and are apparently cured whereas the remaining 60 percent die from the disease Similarly some patients with follicular lymphoma develop aggressive disease within a few years of diagnosis while others have stable disease over 10 to 20 years Although the distinctions in clinical course of these diseases are recognized there are no studies to determine the molecular genetic basis for this variability This study will try to define new molecular diagnostic categories in these diseases and correlate them with clinical features including treatment response disease remission and overall survival following chemotherapy
This retrospective study will use clinical data and tissue samples from participating centers in the LymphomaLeukemia Molecular Profiling Project LLMPP New patients will not be recruited for this study
Biopsy materials including fresh frozen or OTC-embedded lymphoma biopsy material viably frozen samples of peripheral blood cells from leukemia patients and viably frozen samples of bone marrow aspirates from multiple myeloma patients will be collected from pathologists participating in the LLMPP RNA and genomic DNA will be extracted from the tumor samples A variety of technologies will be used to characterize the genome of the cancer cells including lymphochip microarrays for array-based comparative genomic hybridization Southern blotting and PCR for translocation of genes previously implicated in these malignancies and PCR and DNA sequencing methods for analyzing base changes in the genome of the cancer cells Clinical information from the initial diagnosis to disease relapse will be taken from existing databases andor patient charts Gene expression will be correlated with the clinical data If a small number of genes is found to strongly predict clinical outcome quantitative RT-PCR assays using the Taqman technology may be developed as an alternative to DNA microarray analysis
This retrospective study will use clinical data and tissue samples from participating centers in the LymphomaLeukemia Molecular Profiling Project LLMPP New patients will not be recruited for this study
Biopsy materials including fresh frozen or OTC-embedded lymphoma biopsy material viably frozen samples of peripheral blood cells from leukemia patients and viably frozen samples of bone marrow aspirates from multiple myeloma patients will be collected from pathologists participating in the LLMPP RNA and genomic DNA will be extracted from the tumor samples A variety of technologies will be used to characterize the genome of the cancer cells including lymphochip microarrays for array-based comparative genomic hybridization Southern blotting and PCR for translocation of genes previously implicated in these malignancies and PCR and DNA sequencing methods for analyzing base changes in the genome of the cancer cells Clinical information from the initial diagnosis to disease relapse will be taken from existing databases andor patient charts Gene expression will be correlated with the clinical data If a small number of genes is found to strongly predict clinical outcome quantitative RT-PCR assays using the Taqman technology may be developed as an alternative to DNA microarray analysis
Detailed Description:
Current diagnosis of the lymphoid malignancies relies upon the morphological appearance of the cancer cells supplemented by a few molecular markers Within a diagnostic category the clinical courses and responses of patients to therapy are variable suggesting that the existing diagnostic categories may harbor more than one disease entity Recent genomic technologies allow a comprehensive molecular analysis of the expression of the genome in cancer cells DNA microarray analysis of gene expression in lymphomas revealed distinct molecular subtypes of diffuse large B-cell lymphoma and these new molecularly-defined lymphoma subtypes had divergent clinical outcomes To extend our genomic analysis to all lymphoid malignancies we have formed a consortium of cooperating institutions termed the LymphomaLeukemia Molecular Profiling Project LLMPP The clinical centers participating in the LLMPP will send de-identified lymphoma leukemia and multiple myeloma samples to the NCI for gene expression profiling array-based comparative genomic hybridization and cancer gene resequencing An additional site The National Cancer Center Singapore will send de-identified samples of tumor tissue from patients with lymphoma
Objective
Assess gene expression on a genomic scale in lymphoma leukemia and multiple myeloma samples and its relationship to somatic genetic alterations
Eligibility
Diagnosis of lymphoid malignancy at one of the LLMPP participating institutions including specimens originating at other clinical sites and submitted to LLMPP participating sites or The National Cancer Center Singapore
Design
This is an entirely retrospective study All tumor biopsies containing malignant cells to be analyzed were obtained previously from patients diagnosed andor treated at one of the institutions participating in the LLMPP or at The National Cancer Center Singapore
Clinical data will also be sent for the patients in this study for the purpose of correlating gene expression measurements with clinical outcome The goals of this effort are to define new molecular diagnostic categories in these diseases that are clinically relevant and to gain new insight into the molecular pathways that are active in these malignancies
The home institutions providing clinical data and tissue samples have obtained local approval by their clinical research committees for this study
Objective
Assess gene expression on a genomic scale in lymphoma leukemia and multiple myeloma samples and its relationship to somatic genetic alterations
Eligibility
Diagnosis of lymphoid malignancy at one of the LLMPP participating institutions including specimens originating at other clinical sites and submitted to LLMPP participating sites or The National Cancer Center Singapore
Design
This is an entirely retrospective study All tumor biopsies containing malignant cells to be analyzed were obtained previously from patients diagnosed andor treated at one of the institutions participating in the LLMPP or at The National Cancer Center Singapore
Clinical data will also be sent for the patients in this study for the purpose of correlating gene expression measurements with clinical outcome The goals of this effort are to define new molecular diagnostic categories in these diseases that are clinically relevant and to gain new insight into the molecular pathways that are active in these malignancies
The home institutions providing clinical data and tissue samples have obtained local approval by their clinical research committees for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-C-N042 | None | None | None |