Tissue Collection for Studies of Lymph Cancer

NCT01676805 | Recruiting

• 2 other identifiers: 12019312-C-0193
• Study Type: observational
• Target: 1,295
• Locations: 2 countries
• Sites: 2

Brief Summary

Background: \- Lab studies help researchers better understand cancer biology. This information may lead to new methods for diagnosing or treating cancer. To develop these studies, researchers want to collect samples from people with cancer or precancer conditions of the lymph system. These conditions include multiple myeloma, different types of lymphoma, and adult leukemia/lymphoma. The samples collected will include blood, urine, bone marrow, and tumor and skin tissue. Objectives: \- To collect tissue samples to study different types of lymph cancer. Eligibility: \- Individuals at least 18 years of age who have a lymphoid cancer or precancer condition. Design:

• Participants will be screened with a physical exam and medical history.
• Different samples will be collected for study. Blood samples will be collected at the initial testing. More blood samples will be collected at different treatment points. Other liquid samples include urine, bone marrow, and any abnormal fluid. Tumor tissue and skin tissue biopsies will also be collected for study.
• Treatment will not be provided as part of this study.

Conditions

Lymphoma, Non-Hodgkin; Lymphomatoid Granulomatosis; Leukemia-Lymphoma, Adult T-Cell; Hodgkin Disease; Multiple Myeloma

Keywords

Developing Novel Treatment Approaches; Developing Therapeutic Agents; Analysis of Genetic and Genomic Biology; New Prognostic and Diagnostic Models; Analysis of Cellular and Molecular Biology; Natural History

Outcome Measures

Primary Outcomes (1)

• sample acquisition

  Standard exploratory and descriptive statistical methods will be used, as appropriate to the specific biologic assay. Any findings will be reported in the context of this exploratory study, with appropriate caveats.

  ongoing

Secondary Outcomes (5)

• Obtain specimens for genetic analysis, establishment of cell lines, and genomic sequence characterizations

  baseline and other timepoints TBD by PI/

• Obtain normal tissues for the comparative analysis of functional and/or structural genomics

  baseline

• Establish a comprehensive databank of genomic sequence from patients with Burkitt Lymphoma (BL)

  baseline through end of study

• Develop new therapeutic targets using molecular profiling

  after baseline, through end of study

• Assess the use of molecular profiling for pathological diagnosis and response correlation

  baseline through end of study

Study Arms (2)

1

Patients with a known lymphoid malignancy or precursor disease to a lymphoid malignancy

2

Patients without a known lymphoid malignancy or precursor disease to a lymphoid malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary clinical patients seen for a known lymphoid malignancy or precursor disease to a lymphoid malignancy. Patients without a known lymphoid malignancy or precursor disease to a lymphoid malignancy being seen at NIH for another study and who are willing to contribute samples also to this study.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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:
• 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
• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

University of the West Indies

Kingston, Jamaica

TERMINATED

Related Publications (3)

• Rosenwald A, Wright G, Chan WC, Connors JM, Campo E, Fisher RI, Gascoyne RD, Muller-Hermelink HK, Smeland EB, Giltnane JM, Hurt EM, Zhao H, Averett L, Yang L, Wilson WH, Jaffe ES, Simon R, Klausner RD, Powell J, Duffey PL, Longo DL, Greiner TC, Weisenburger DD, Sanger WG, Dave BJ, Lynch JC, Vose J, Armitage JO, Montserrat E, Lopez-Guillermo A, Grogan TM, Miller TP, LeBlanc M, Ott G, Kvaloy S, Delabie J, Holte H, Krajci P, Stokke T, Staudt LM; Lymphoma/Leukemia Molecular Profiling Project. The use of molecular profiling to predict survival after chemotherapy for diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jun 20;346(25):1937-47. doi: 10.1056/NEJMoa012914.

  PMID: 12075054 BACKGROUND

• Lenz G, Staudt LM. Aggressive lymphomas. N Engl J Med. 2010 Apr 15;362(15):1417-29. doi: 10.1056/NEJMra0807082.

  PMID: 20393178 BACKGROUND

• Rosenwald A, Wright G, Leroy K, Yu X, Gaulard P, Gascoyne RD, Chan WC, Zhao T, Haioun C, Greiner TC, Weisenburger DD, Lynch JC, Vose J, Armitage JO, Smeland EB, Kvaloy S, Holte H, Delabie J, Campo E, Montserrat E, Lopez-Guillermo A, Ott G, Muller-Hermelink HK, Connors JM, Braziel R, Grogan TM, Fisher RI, Miller TP, LeBlanc M, Chiorazzi M, Zhao H, Yang L, Powell J, Wilson WH, Jaffe ES, Simon R, Klausner RD, Staudt LM. Molecular diagnosis of primary mediastinal B cell lymphoma identifies a clinically favorable subgroup of diffuse large B cell lymphoma related to Hodgkin lymphoma. J Exp Med. 2003 Sep 15;198(6):851-62. doi: 10.1084/jem.20031074.

  PMID: 12975453 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin; Multiple Myeloma; Lymphomatoid Granulomatosis; Leukemia-Lymphoma, Adult T-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoma, B-Cell; Precancerous Conditions; Leukemia, T-Cell; Leukemia, Lymphoid; Leukemia

Study Officials

• Christopher J Melani, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NCIMO Referral Office

CONTACT

(888) 624-1937; ncimo_referrals@mail.nih.gov

Christopher J Melani, M.D.

CONTACT

(240) 760-6057; christopher.melani@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: August 31, 2012
• Study Start: September 21, 2012
• Last Updated: May 5, 2026

Record last verified: 2026-04-30

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: All IPD recorded in the medical record will be shared with intramural investigators upon request. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.

Locations

JA (1); US (1)