ClinicalTrials.gov record NCT01137643
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Tissue Procurement For Hematolymphoid Conditions
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective observational study collects and stores tissue, blood, and body-fluid samples from people being evaluated for hematologic cancers. Samples are taken during diagnostic or routine clinical procedures and kept for future research. Sample types may include lymph node or other biopsies, bone marrow aspirates/biopsies, blood and serum, and buccal swabs.
What it is studying. The study is creating a centralized collection of patient tissue, blood, and body-fluid samples to support future diagnostic, prognostic, and immune-monitoring laboratory studies and to provide material for researchers.
What the researchers hope to learn. Provide a source of patient tissue, blood, and body-fluid samples for diagnostic, prognostic, or immune-monitoring studies; support translational, clinical, and basic research for Lineberger Comprehensive Cancer Center members and approved collaborators; maintain policies protecting patient privacy and responsible research conduct; coordinate specimen collection and support pilot data for young investigators.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- biologic sample preservation procedure
- cytology specimen collection procedure
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion 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 description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
If you agree to participate, tissue, blood, and body-fluid samples that are taken as part of your diagnostic or routine clinical care may be collected and stored for research. Samples may include lymph node or non-nodal biopsies and bone marrow biopsy and/or aspirate (these can be invasive), plus blood and serum and buccal (cheek) swabs for germline DNA. Collected samples will be preserved and kept for future correlative studies such as diagnostic, prognostic, or immune-monitoring research. The study maintains policies for coordinated specimen handling and to protect participant privacy and confidentiality.
How the study is structured. This is a prospective observational sample-collection program. Participants do not receive experimental treatments as part of the study; biological samples collected during routine diagnostic or clinical care are processed, stored, and made available for IRB-approved research. The program includes procedures to centralize, quality-control, and store specimens for long-term use (outcomes tracked up to 30 years).
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on large granular lymphocytic leukemia
This trial is also listed on this site under AL amyloidosis, splenic marginal zone lymphoma and Waldenström macroglobulinemia.
Important dates
- Study start
- July 2009
- Primary completion
- July 2040 (estimated)
- Study completion
- July 2040 (estimated)
- Target enrollment
- 15000 participants (estimated)
- Last updated on registry
- Oct 27, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Collaborators
- National Cancer Institute (NCI)
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Paul Armistead, MD 📞 (919) 843-6847 ✉ paul_armistead@med.unc.edu
Participating sites (1)
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillRecruiting
Chapel Hill, North Carolina, 27599-7295 · United States
- Tissue Procurement Facility · 919-966-2620
Terms used on this page · explanations by MedicalUpdates.ai
- stem cell transplant
- A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
- sponsor
- The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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