RecruitingNCT01137643Updated Oct 27, 2025

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

An observational study in Chronic Myeloproliferative Disorders, Leukemia and Lymphoma, sponsored by UNC Lineberger Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-10-27.

Sponsored by UNC Lineberger Comprehensive Cancer Center · Observational

Study type: Observational
Model: Other
Time perspective: Prospective
Enrollment: 15,000
Ages: 18 Years to 120 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Nonmalignant Neoplasm

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Keywords

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
stage IV chronic lymphocytic leukemia
T-cell large granular lymphocyte leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
untreated hairy cell leukemia
recurrent adult Hodgkin lymphoma
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
cutaneous B-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent mycosis fungoides/Sezary syndrome
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
adult grade III lymphomatoid granulomatosis
adult nasal type extranodal NK/T-cell lymphoma
Waldenstrom macroglobulinemia
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
contiguous stage II adult Burkitt lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult lymphoblastic lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
contiguous stage II mantle cell lymphoma
contiguous stage II marginal zone lymphoma
contiguous stage II small lymphocytic lymphoma
stage I adult Burkitt lymphoma
stage I adult diffuse large cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage I adult lymphoblastic lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage I mantle cell lymphoma
stage I marginal zone lymphoma
stage I small lymphocytic lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II marginal zone lymphoma
noncontiguous stage II small lymphocytic lymphoma
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult grade III lymphomatoid granulomatosis
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
intraocular lymphoma
post-transplant lymphoproliferative disorder
chronic eosinophilic leukemia
chronic neutrophilic leukemia
primary myelofibrosis
essential thrombocythemia
polycythemia vera
extramedullary plasmacytoma
isolated plasmacytoma of bone
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
primary systemic amyloidosis
refractory multiple myeloma
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
myelodysplastic/myeloproliferative neoplasm, unclassifiable
aplastic anemia

Who can participate

Ages eligible: 18 Years to 120 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Hematologic malignancies

Eligibility 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

Study design

Observational model: Other
Time perspective: Prospective
Enrollment: 15,000 participants (estimated)
Biospecimen retention: Samples with dna

Interventions

Otherbiologic sample preservation procedure
All samples collected during routine clinical care.
Othercytology specimen collection procedure
All Samples collected during routine clinical care.

What researchers measure

Primary outcomes

Tissue, blood, and body fluid samples collection for ongoing diagnostic, prognostic, or immune-monitoring studies
Time frame: 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

Study locations

1 of 1 sites recruiting

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina 27599-7295, United States
- Tissue Procurement Facility · Contact · 919-966-2620
Recruiting

References and documents

Registry details

Key details

Study ID: NCT01137643
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jun 4, 2010
Start date: Jul 2009
Primary completion: Jul 2040 (estimated)
Completion: Jul 2040 (estimated)
Last update: Oct 27, 2025

Study contacts

Paul Armistead, MD

Contact

paul_armistead@med.unc.edu

(919) 843-6847

Paul Armistead, MD

principal investigator · UNC Lineberger Comprehensive Cancer Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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