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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01137643
First received: June 3, 2010
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
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
Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Tissue Procurement For Hematolymphoid Conditions

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Aplastic Anemia Lymphoma, Small Cleaved-cell, Diffuse Lymphosarcoma B-cell Lymphomas Follicular Lymphoma Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Acute Myeloid Leukemia, Adult Multiple Myeloma Acute Lymphoblastic Leukemia Cutaneous T-cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Waldenstrom Macroglobulinemia Hodgkin Lymphoma Mantle Cell Lymphoma Burkitt Lymphoma Lymphoma, Large-cell Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Hairy Cell Leukemia Lymphomatoid Granulomatosis Chronic Myeloproliferative Disorders Myelodysplastic/myeloproliferative Disease Large Granular Lymphocyte Leukemia Mycosis Fungoides Sezary Syndrome Anaplastic Large Cell Lymphoma Leukemia, T-cell, Chronic Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Myelofibrosis Polycythemia Vera Essential Thrombocythemia Hypereosinophilic Syndrome AL Amyloidosis Systemic Mastocytosis Anaplastic Plasmacytoma Chronic Neutrophilic Leukemia
U.S. FDA Resources

Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Tissue, blood, and body fluid samples collection for ongoing diagnostic, prognostic, or immune-monitoring studies [ Time Frame: 30 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tumor tissue, blood, bone marrow, urine, ascites


Estimated Enrollment: 15000
Study Start Date: July 2009
Estimated Primary Completion Date: July 2040 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137643

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente    877-668-0683      
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Kristy Richards, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01137643     History of Changes
Other Study ID Numbers: LCCC 0824, P30CA016086, CDR0000674072
Study First Received: June 3, 2010
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
aplastic anemia
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

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Lymphoma
Leukemia
Disease
Syndrome
Myeloproliferative Disorders
Lymphoproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Lymphatic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014