LeukemiaNCT00339963
Genome Expression in Lymphoma, Leukemia and Multiple Myeloma
An observational study of Leukemia and Multiple Myeloma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Leukemia, Multiple Myeloma, Hodgkin Lymphoma
- How many people
- 1,340 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2001to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed and/or treated at one of the institutions participating in the LLMPP or at The National Cancer Center Singapore.@@@
Who may be able to join
- 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 National Cancer Center Singapore.
- Informed consent for research studies performed on biopsy material or waiver of the requirement for informed consent by the clinical research review boards at the LLMPP institutions or National Cancer Center Singapore.
- Sufficient frozen biopsy and/or FFPE material from initial biopsy and/or biopsies at relapse of disease to obtain adequate RNA and DNA for gene expression profiling and analysis of genomic alterations in the malignant cells.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Expression of the Genome in Lymphoid Malignancies
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 Lymphoma/Leukemia 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 and/or 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.
Read the 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 Lymphoma/Leukemia 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 and/or 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.
- Conditions
- Leukemia, Multiple Myeloma, Hodgkin Lymphoma, Lymphoma, Non-Hodgkin
- Keywords
- Microarray, Lymphoma, Gene Expression, Molecular Diagnosis, Prognosis, Natural History, Leukemia, Myeloma, Lymphoid Malignancy
- Medical subject headings
- Leukemia, Multiple Myeloma, Hodgkin Disease, Lymphoma, Non-Hodgkin, Lymphoma, Neoplasms, Plasma Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression on a genomic scale in lymphoma, leukemia and multiple myeloma samples.
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.
Measured: Every year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start9 Nov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Lymphoma/Leukemia Molecular Profiling Project (LLMPP)
- Responsible party
- Sponsor
- Investigators
- Louis M Staudt, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339963
- Sponsor's protocol ID
- 999902042
- Other IDs
- 02-C-N042
- Status last verified
- 11 Feb 2026
- First submitted
- 19 Jun 2006
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gascoyne RD, Adomat SA, Krajewski S, Krajewska M, Horsman DE, Tolcher AW, O'Reilly SE, Hoskins P, Coldman AJ, Reed JC, Connors JM. Prognostic significance of Bcl-2 protein expression and Bcl-2 gene rearrangement in diffuse aggressive non-Hodgkin's lymphoma. Blood. 1997 Jul 1;90(1):244-51.
PubMed 9207459Vose JM. Current approaches to the management of non-Hodgkin's lymphoma. Semin Oncol. 1998 Aug;25(4):483-91.
PubMed 9728598Harris NL, Jaffe ES, Stein H, Banks PM, Chan JK, Cleary ML, Delsol G, De Wolf-Peeters C, Falini B, Gatter KC, et al. A revised European-American classification of lymphoid neoplasms: a proposal from the International Lymphoma Study Group. Blood. 1994 Sep 1;84(5):1361-92. No abstract available.
PubMed 8068936
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of the Genome in Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT00339963
- Acronym / sponsor ID
- 999902042
- Conditions
- Leukemia, Multiple Myeloma, Hodgkin Lymphoma, Lymphoma, Non-Hodgkin
- Keywords
- Microarray, Lymphoma, Gene Expression, Molecular Diagnosis, Prognosis, Natural History, Leukemia, Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,340 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- Lymphoma/Leukemia Molecular Profiling Project (LLMPP)
- Study start
- 9 Nov 2001
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Lymphoma/Leukemia 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 and/or 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 Lymphoma/Leukemia 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 and/or 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed and/or treated at one of the institutions participating in the LLMPP or at The National Cancer Center Singapore.@@@
Key inclusion criteria (3 listed)
- 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 National Cancer Center Singapore.
- Informed consent for research studies performed on biopsy material or waiver of the requirement for informed consent by the clinical research review boards at the LLMPP institutions or National Cancer Center Singapore.
- Sufficient frozen biopsy and/or FFPE material from initial biopsy and/or biopsies at relapse of disease to obtain adequate RNA and DNA for gene expression profiling and analysis of genomic alterations in the malignant cells.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gene expression on a genomic scale in lymphoma, leukemia and multiple myeloma samples.
Time frame: Every year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 9207459Gascoyne RD, Adomat SA, Krajewski S, Krajewska M, Horsman DE, Tolcher AW, O'Reilly SE, Hoskins P, Coldman AJ, Reed JC, Connors JM. Prognostic significance of Bcl-2 protein expression and Bcl-2 gene rearrangement in diffuse aggressive non-Hodgkin's lymphoma. Blood. 1997 Jul 1;90(1):244-51.
- Background: PubMed 9728598Vose JM. Current approaches to the management of non-Hodgkin's lymphoma. Semin Oncol. 1998 Aug;25(4):483-91.
- Background: PubMed 8068936Harris NL, Jaffe ES, Stein H, Banks PM, Chan JK, Cleary ML, Delsol G, De Wolf-Peeters C, Falini B, Gatter KC, et al. A revised European-American classification of lymphoid neoplasms: a proposal from the International Lymphoma Study Group. Blood. 1994 Sep 1;84(5):1361-92. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis M Staudt, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Multiple Myeloma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression on a genomic scale in lymphoma, leukemia and multiple myeloma samples. (time frame: Every year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339963, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.