- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01137643
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Tissue Procurement For Hematolymphoid Conditions
RATIONALE: Collecting and storing samples of tissue, blood, and body fluid from patients with cancer to study in the laboratory may help the study of cancer in the future.
PURPOSE: This research study is collecting and storing blood and tissue samples from patients being evaluated for hematologic cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Provide source of patient tissue, blood, and body fluid samples for ongoing diagnostic, prognostic, or immune-monitoring studies.
- Support and enhance translational, clinical and basic research for Lineberger Comprehensive Cancer Center (LCCC) members (and non-members who have an LCCC member as sponsor and collaborator) with IRB-approved studies.
- Maintain responsible and appropriate policies and procedures that ensure good patient care and responsible conduct of research.
- Address medical and legal issues, and protect participant and patient privacy and confidentiality.
- Provide a responsible and uniform mechanism for the integrated coordination of the hemato-pathologist and surgeon or hematology/oncology staff, researcher, and protocol office to obtain appropriate specimens for researchers.
- Support young investigators to obtain pilot data for grant funding.
OUTLINE: Patients undergo tissue, blood, and body fluid collection during diagnostic or routine procedures for future correlative studies. Tissue samples may include, but are not limited to, lymph node or non-nodal biopsies, bone marrow biopsy and/or aspirate, blood and serum, and buccal swabs for germline DNA analysis.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Paul Armistead, MD
- Phone Number: (919) 843-6847
- Email: paul_armistead@med.unc.edu
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Recruiting
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
Contact:
- Tissue Procurement Facility
- Phone Number: 919-966-2620
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
Diagnosis of abnormal hematopoietic/lymphoid cancer, including any of the following:
- Acute myeloid leukemia
- Acute lymphoblastic leukemia
- Chronic myelogenous leukemia
- Chronic lymphoid leukemia
- Non-Hodgkin lymphoma
- Hodgkin lymphoma
- Myelodysplastic syndromes
- Myeloproliferative disorders
- Multiple myeloma
- Waldenstrom macroglobulinemia
- Aplastic anemia
- Any other diseases that generate abnormalities in either number, function, or both of any cell type of hematolymphoid lineage
- Patients who are being evaluated at the hematology/oncology clinics of the University of North Carolina Hospitals, at the stem cell transplant clinic, or in the hospital
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Tissue, blood, and body fluid samples collection for ongoing diagnostic, prognostic, or immune-monitoring studies
Time Frame: 30 years
|
30 years
|
|
Development of a centralized, quality-controlled, quality-assured facility for the procurement, processing, storage, and distribution of normal and malignant tissue specimens and corresponding blood specimens
Time Frame: 30 years
|
30 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Paul Armistead, MD, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- primary myelofibrosis
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage I mycosis fungoides/Sezary syndrome
- stage 0 chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- 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)
- secondary acute myeloid leukemia
- primary systemic amyloidosis
- recurrent adult acute myeloid leukemia
- untreated adult acute myeloid leukemia
- adult acute myeloid leukemia in remission
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- Waldenstrom macroglobulinemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage II multiple myeloma
- stage III multiple myeloma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- stage I multiple myeloma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- aplastic anemia
- refractory chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- intraocular lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- adult grade III lymphomatoid granulomatosis
- adult nasal type extranodal NK/T-cell lymphoma
- recurrent adult grade III lymphomatoid granulomatosis
- post-transplant lymphoproliferative disorder
- cutaneous B-cell non-Hodgkin lymphoma
- refractory multiple myeloma
- recurrent adult acute lymphoblastic leukemia
- polycythemia vera
- essential thrombocythemia
- refractory hairy cell leukemia
- prolymphocytic leukemia
- contiguous stage II mantle cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- atypical chronic myeloid leukemia, BCR-ABL negative
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- stage I mantle cell lymphoma
- isolated plasmacytoma of bone
- extramedullary plasmacytoma
- acute undifferentiated leukemia
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage I adult Burkitt lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- untreated adult acute lymphoblastic leukemia
- meningeal chronic myelogenous leukemia
- contiguous stage II grade 3 follicular lymphoma
- stage I grade 3 follicular lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage II mycosis fungoides/Sezary syndrome
- mast cell leukemia
- progressive hairy cell leukemia, initial treatment
- stage I adult T-cell leukemia/lymphoma
- stage II adult T-cell leukemia/lymphoma
- T-cell large granular lymphocyte leukemia
- untreated hairy cell leukemia
- contiguous stage II adult lymphoblastic lymphoma
- stage I adult lymphoblastic lymphoma
Additional Relevant MeSH Terms
- Bone Marrow Failure Disorders
- Lymphadenopathy
- Mast Cell Activation Disorders
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Neoplasms by Site
- Chronic Disease
- Disease Attributes
- Metabolic Diseases
- Immune System Diseases
- Infections
- Virus Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Neoplastic Processes
- DNA Virus Infections
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Blood Coagulation Disorders
- Lymphoma, B-Cell
- Leukemia, Myeloid
- Bone Marrow Diseases
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Anemia
- Leukemia, Lymphoid
- Epstein-Barr Virus Infections
- Herpesviridae Infections
- Tumor Virus Infections
- Blood Platelet Disorders
- Proteostasis Deficiencies
- Eye Neoplasms
- Bone Marrow Neoplasms
- Hematologic Neoplasms
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Cell Transformation, Neoplastic
- Carcinogenesis
- Leukemia, T-Cell
- Lymphoma, T-Cell
- Mastocytosis, Systemic
- Mastocytosis
- Amyloidosis
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Hemic and Lymphatic Diseases
- Thrombocytosis
- Immunoglobulin Light-chain Amyloidosis
- Congenital Abnormalities
- Neoplasms
- Leukemia
- Leukemia, Myeloid, Acute
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Leukemia, Lymphocytic, Chronic, B-Cell
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Burkitt Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Follicular
- Myelodysplastic Syndromes
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Hodgkin Disease
- Lymphoma, Large-Cell, Anaplastic
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
- Anemia, Aplastic
- Lymphoproliferative Disorders
- Leukemia, Prolymphocytic
- Thrombocythemia, Essential
- Polycythemia Vera
- Lymphoma, Mantle-Cell
- Primary Myelofibrosis
- Waldenstrom Macroglobulinemia
- Lymphoma, T-Cell, Cutaneous
- Lymphoma, Large-Cell, Immunoblastic
- Lymphoma, B-Cell, Marginal Zone
- Blast Crisis
- Leukemia, Biphenotypic, Acute
- Leukemia, Large Granular Lymphocytic
- Leukemia, Myeloid, Accelerated Phase
- Mycosis Fungoides
- Sezary Syndrome
- Lymphoma, Extranodal NK-T-Cell
- Immunoblastic Lymphadenopathy
- Leukemia, Hairy Cell
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
- Leukemia, Neutrophilic, Chronic
- Leukemia, Mast-Cell
- Intraocular Lymphoma
- Pdgfra-Associated Chronic Eosinophilic Leukemia
Other Study ID Numbers
- LCCC 0824
- P30CA016086 (U.S. NIH Grant/Contract)
- CDR0000674072 (Other Identifier: PDQ number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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