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Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01137643
Recruitment Status : Active, not recruiting
First Posted : June 4, 2010
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment
Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Nonmalignant Neoplasm Other: biologic sample preservation procedure Other: cytology specimen collection procedure

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.

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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Tissue Procurement For Hematolymphoid Conditions
Study Start Date : July 2009
Estimated Primary Completion Date : July 2040
Estimated Study Completion Date : July 2040



Intervention Details:
  • Other: biologic sample preservation procedure
    All samples collected during routine clinical care.
  • Other: cytology specimen collection procedure
    All Samples collected during routine clinical care.


Primary Outcome Measures :
  1. Tissue, blood, and body fluid samples collection for ongoing diagnostic, prognostic, or immune-monitoring studies [ Time Frame: 30 years ]
  2. 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 ]

Biospecimen Retention:   Samples With DNA
Tumor tissue, blood, bone marrow, urine, ascites


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hematologic malignancies
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137643


Locations
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United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Paul Armistead, MD UNC Lineberger Comprehensive Cancer Center
Additional Information:
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01137643    
Other Study ID Numbers: LCCC 0824
P30CA016086 ( U.S. NIH Grant/Contract )
CDR0000674072 ( Other Identifier: PDQ number )
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
accelerated phase chronic myelogenous leukemia
acute undifferentiated 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
mast cell leukemia
meningeal chronic myelogenous leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult T-cell leukemia/lymphoma
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
stage 0 chronic lymphocytic leukemia
stage I adult T-cell leukemia/lymphoma
stage I chronic lymphocytic leukemia
stage II adult T-cell leukemia/lymphoma
stage II chronic lymphocytic leukemia
stage III adult T-cell leukemia/lymphoma
stage III chronic lymphocytic leukemia
stage IV adult T-cell leukemia/lymphoma
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders
Lymphoproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Disease
Syndrome
Neoplasms
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions