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

Lymphoma Clinical Trial

Official title:

Tissue Procurement For Hematolymphoid Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01137643
• Other study ID #: LCCC 0824
• Secondary ID: P30CA016086CDR00
• Status: Recruiting
• Start date: July 2009
• Est. completion date: July 2040

Study information

• Verified date: October 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Paul Armistead, MD
• Phone: (919) 843-6847
• Email: paul_armistead[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: July 2040
• Est. primary completion date: July 2040
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Nonmalignant Neoplasm
• Plasmacytoma
• Preleukemia
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue, blood, and body fluid samples collection for ongoing diagnostic, prognostic, or immune-monitoring studies		30 years
Primary	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		30 years

External Links

•   Web address for UNC Lineberger Comprehensive Cancer Center