Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-04-18 @ 6:37 AM
Study NCT ID:
NCT01676805
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2012-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Collection for Studies of Lymph Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Lymphoid Malignancies and Precursors: Tissue Acquisition Protocol
Status:
RECRUITING
Status Verified Date:
2025-09-09
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:
Background:
\- Lab studies help researchers better understand cancer biology. This information may lead to new methods for diagnosing or treating cancer. To develop these studies, researchers want to collect samples from people with cancer or precancer conditions of the lymph system. These conditions include multiple myeloma, different types of lymphoma, and adult leukemia/lymphoma. The samples collected will include blood, urine, bone marrow, and tumor and skin tissue.
Objectives:
\- To collect tissue samples to study different types of lymph cancer.
Eligibility:
\- Individuals at least 18 years of age who have a lymphoid cancer or precancer condition.
Design:
* Participants will be screened with a physical exam and medical history.
* Different samples will be collected for study. Blood samples will be collected at the initial testing. More blood samples will be collected at different treatment points. Other liquid samples include urine, bone marrow, and any abnormal fluid. Tumor tissue and skin tissue biopsies will also be collected for study.
* Treatment will not be provided as part of this study.
\- Lab studies help researchers better understand cancer biology. This information may lead to new methods for diagnosing or treating cancer. To develop these studies, researchers want to collect samples from people with cancer or precancer conditions of the lymph system. These conditions include multiple myeloma, different types of lymphoma, and adult leukemia/lymphoma. The samples collected will include blood, urine, bone marrow, and tumor and skin tissue.
Objectives:
\- To collect tissue samples to study different types of lymph cancer.
Eligibility:
\- Individuals at least 18 years of age who have a lymphoid cancer or precancer condition.
Design:
* Participants will be screened with a physical exam and medical history.
* Different samples will be collected for study. Blood samples will be collected at the initial testing. More blood samples will be collected at different treatment points. Other liquid samples include urine, bone marrow, and any abnormal fluid. Tumor tissue and skin tissue biopsies will also be collected for study.
* Treatment will not be provided as part of this study.
Detailed Description:
Background:
-An estimated 79,190 people living in the United States will be diagnosed with lymphoma in 2012, including 9,060 cases of HL, 70,130 cases of non-Hodgkin s lymphoma (NHL) and multiple cases of adult T-cell leukemia/lymphoma. Laboratory investigations conducted in the Lymphoid Malignancies Branch, including analysis of cellular, molecular, genetic and genomic biology are attempting to develop new prognostic and diagnostic models, therapeutic agents and novel treatment approaches for lymphoid malignancies and pre malignant conditions.
Objectives:
-This biology protocol is designed to allow sample acquisition for use in the study of lymphoid malignancies and malignancy precursors, including but not limited to B and T cell malignancies, such as diffuse large B-cell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL) as well as comparison to tissues from patients without lymphoid disease. A variety of laboratory investigations will be conducted on blood, tumor, bone marrow, urine, abnormal fluid and normal tissue, including analysis of cellular, molecular, genetic and genomic biology in the support of NIH translational trials to develop new therapeutic agents and novel treatment approaches as well as new prognostic and diagnostic models.
Eligibility:
-Adult patients who meet one of the following:
* Confirmed pathological diagnosis of lymphoid malignancy or lymphoid precursor, including B-cell and T-cell lymphomas: including but not limited to diffuse large Bcell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL).
* No known lymphoid malignancy or lymphoid precursor diagnosis and planning a surgical procedure during which blood or normal lymph node(s)/tissue (i.e., those not with pre-determined likelihood of abnormality/malignancy) may be obtained for research studies as part of this protocol.
Design:
* The purpose of this study is to examine, in an exploratory fashion, a variety of biologic assays relevant to the investigation of lymphoid malignancies.
* It is anticipated that up to 60 consented subjects will be studied each year. To account for these anticipated 60 consented subjects in addition to up to potentially 5 screen fails each year an accrual ceiling of 650 consented subjects is planned over 10 years. To account for samples transferred from other studies, a total accrual ceiling of 1,292 has been set.
-An estimated 79,190 people living in the United States will be diagnosed with lymphoma in 2012, including 9,060 cases of HL, 70,130 cases of non-Hodgkin s lymphoma (NHL) and multiple cases of adult T-cell leukemia/lymphoma. Laboratory investigations conducted in the Lymphoid Malignancies Branch, including analysis of cellular, molecular, genetic and genomic biology are attempting to develop new prognostic and diagnostic models, therapeutic agents and novel treatment approaches for lymphoid malignancies and pre malignant conditions.
Objectives:
-This biology protocol is designed to allow sample acquisition for use in the study of lymphoid malignancies and malignancy precursors, including but not limited to B and T cell malignancies, such as diffuse large B-cell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL) as well as comparison to tissues from patients without lymphoid disease. A variety of laboratory investigations will be conducted on blood, tumor, bone marrow, urine, abnormal fluid and normal tissue, including analysis of cellular, molecular, genetic and genomic biology in the support of NIH translational trials to develop new therapeutic agents and novel treatment approaches as well as new prognostic and diagnostic models.
Eligibility:
-Adult patients who meet one of the following:
* Confirmed pathological diagnosis of lymphoid malignancy or lymphoid precursor, including B-cell and T-cell lymphomas: including but not limited to diffuse large Bcell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL).
* No known lymphoid malignancy or lymphoid precursor diagnosis and planning a surgical procedure during which blood or normal lymph node(s)/tissue (i.e., those not with pre-determined likelihood of abnormality/malignancy) may be obtained for research studies as part of this protocol.
Design:
* The purpose of this study is to examine, in an exploratory fashion, a variety of biologic assays relevant to the investigation of lymphoid malignancies.
* It is anticipated that up to 60 consented subjects will be studied each year. To account for these anticipated 60 consented subjects in addition to up to potentially 5 screen fails each year an accrual ceiling of 650 consented subjects is planned over 10 years. To account for samples transferred from other studies, a total accrual ceiling of 1,292 has been set.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 12-C-0193 | None | None | View |