Collecting tissue samples to study lymph cancer

Lymphoid Malignancies and Precursors: Tissue Acquisition Protocol

This study is collecting tissue samples from people with lymphoid cancers to learn more about the disease and help create better treatments.

Quick facts

• Study type: Observational
• Enrollment: 1295 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 2 sites (Bethesda, Maryland and 1 other locations)
• Trial ID: NCT01676805 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect various tissue samples from individuals diagnosed with lymphoid cancers or precancerous conditions, including multiple myeloma and different types of lymphoma. Participants will undergo screening through physical exams and medical history assessments, followed by the collection of blood, urine, bone marrow, and tumor tissues. The samples will be analyzed to enhance understanding of cancer biology and to develop new diagnostic and therapeutic approaches. The research is conducted by the National Cancer Institute to support translational trials in lymphoid malignancies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of lymphoid malignancy or precursor conditions.

Not a fit: Patients without a diagnosis of lymphoid malignancy or those under 18 years of age may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and treatment options for patients with lymphoid cancers.

How similar studies have performed: Other studies have shown success in using tissue samples to advance understanding and treatment of lymphoid malignancies, making this approach both relevant and promising.

Eligibility criteria

* Lymphoid Malignancies/Diseases:

INCLUSION CRITERIA:

* Patients with a known lymphoid malignancy or precursor disease to a lymphoid malignancy, including multiple myeloma, B-cell and T-cell lymphomas: including but not limited to diffuse large B-cell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL).
* Confirmation of pathological diagnosis is required from the Laboratory of Pathology, NCI. Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the subject during sampling required for routine patient care or required testing on an NIH research protocol will be used for diagnosis.
* Age \>= 18 years of age
* ECOG performance 0-2
* Ability of patient or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document NOTE: Patients enrolling with a LAR must be co-enrolled on another study.

INCLUSION FOR APHERESIS:

NOTE: This is optional in all patients and will only be requested if the patient is willing, timing allows, and the following criteria are met.

* Hemoglobin \>= 10 mg/dL and platelet count \> 75 K/uL
* Weight greater than 25 kg
* HIV negative
* Prothrombin Time - within normal limits
* Partial Thromboplastin Time - within normal limits
* Medically indicated central line in place or adequate peripheral venous access

EXCLUSION CRITERIA:

* Pregnant individuals will not be eligible.
* Active symptomatic major organ disorder that would increase the risk of biopsy or apheresis, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.
* Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.

NON-LYMPHOID MALIGNANCIES/DISEASES: The following criteria apply only to patients without a known lymphoid malignancy or precursor disease, as described:

INCLUSION CRITERIA:

-Patients without a known lymphoid malignancy or lymphoid precursor diagnosis who have a planned surgical procedure during which blood or normal lymph node(s)/tissue (i.e., those not with pre-determined likelihood of abnormality/ malignancy) may be obtained for research studies as part of this protocol

Patient is appropriate to undergo the surgical procedure planned, and consented for the same, as needed. NOTE: This study will not evaluate eligibility of the patient for surgery.

* Age \>= 18 years of age
* Must be able and willing to sign informed consent

EXCLUSION CRITERIA:

* Pregnant individuals will not be eligible
* Other active malignancy. NOTE: Patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin as well as any in situ carcinoma are eligible. Patients with a malignancy that has been treated with curative intent and who are without evidence of disease for \>=2 years will also be eligible at the discretion of the investigator.
* Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.

Where this trial is running

Bethesda, Maryland and 1 other locations

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
• University of the West Indies — Kingston, Jamaica (TERMINATED)

Study contacts

• Principal investigator: Christopher J Melani, M.D. — National Cancer Institute (NCI)
• Study coordinator: NCIMO Referral Office

Conditions: Hodgkin Disease, Lymphoma, Non-Hodgkin, Multiple Myeloma, Lymphomatoid Granulomatosis, Leukemia-Lymphoma, Adult T-Cell, Developing Novel Treatment Approaches, Developing Therapeutic Agents, Analysis of Genetic and Genomic Biology