ClinicalTrials.gg
RecruitingNCT01676805Updated Oct 26, 2026

Tissue Collection for Studies of Lymph Cancer

An observational study in Hodgkin Disease, Lymphoma, Non-Hodgkin and Multiple Myeloma, sponsored by National Cancer Institute (NCI). Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by National Cancer Institute (NCI) · Observational

From the registry’s dates

  • Started Sep 2012; still recruiting 14 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,295
Ages
18 Years and older
Sex
All
01

Study 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.
Read the detailed description

Background:

-An estimated 79,190 people living in the United States will be diagnosed with lymphoma in 2012, including 9,060 cases of HL, 70,130 cases of non-Hodgkin's lymphoma (NHL) and multiple cases of adult T-cell leukemia/lymphoma. Laboratory investigations conducted in the Lymphoid Malignancies Branch, including analysis of cellular, molecular, genetic and genomic biology are attempting to develop new prognostic and diagnostic models, therapeutic agents and novel treatment approaches for lymphoid malignancies and pre-malignant conditions.

Objectives:

-This biology protocol is designed to allow sample acquisition for use in the study of lymphoid malignancies and malignancy precursors, including but not limited to B and T cell malignancies, such as diffuse large B-cell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL) as well as comparison to tissues from patients without lymphoid disease. A variety of laboratory investigations will be conducted on blood, tumor, bone marrow, urine, abnormal fluid and normal tissue, including analysis of cellular, molecular, genetic and genomic biology in the support of NIH translational trials to develop new therapeutic agents and novel treatment approaches as well as new prognostic and diagnostic models.

Eligibility:

-Adult patients who meet one of the following:

  • Confirmed pathological diagnosis of lymphoid malignancy or lymphoid precursor, including B-cell and T-cell lymphomas: including but not limited to diffuse large Bcell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL).
  • No known lymphoid malignancy or lymphoid precursor diagnosis and planning a 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.

Design:

  • The purpose of this study is to examine, in an exploratory fashion, a variety of biologic assays relevant to the investigation of lymphoid malignancies.
  • It is anticipated that up to 60 consented subjects will be studied each year. To account for these anticipated 60 consented subjects in addition to up to potentially 5 screen fails each year an accrual ceiling of 650 consented subjects was initially planned over the first 10 years of study. To account for additional consented subjects after the first 10 years of study in addition to samples transferred from other studies, the total accrual ceiling has been increased to 1,292 subjects.
02

Conditions studied

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

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
03

In context

Hodgkin Disease

1,383 studies on the registry are indexed under Hodgkin Disease; 163 are open to participants now.

This study's planned enrollment of 1,295 is above the median of 123 across 161 observational studies indexed under Hodgkin Disease.

Browse Hodgkin Disease studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

  • LYMPHOID /DISEASES: The following criteria apply only to patients with a known lymphoid malignancy or precursor

disease, as described:

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
  • Ability of patient or Legally Authorized Representative (LAR) to understand and the willingness to sign a written document NOTE: Patients enrolling with a LAR must be co-enrolled on another study.

EXCLUSION CRITERIA:

  • Pregnant individuals will not be eligible.
  • Active symptomatic major organ disorder that would increase the risk of , including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, and/or 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,295 participants (estimated)

Groups and cohorts

  • 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

06

What researchers measure

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.

    Time frame: ongoing

Secondary outcomes

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

    Genetic analysis, establishment of cell lines, and genomic sequence characterizations will be performed through genetic/genomic studies including analysis of mutations or single nucleotide polymorphisms (SNPs), comparative genomic hybridization, whole genome sequencing, messenger and microRNA sequencing and expression, DNA methylation analysis, DNA copy number analysis, and expression profiling.

    Time frame: baseline and other timepoints TBD by PI/

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

    Blood, tumor, blood plasma, bone marrow, cheek swabs and abnormal fluids will be obtained from patients without a known lymphoid malignancy or precursor disease to a lymphoid malignancy.

    Time frame: baseline

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

    Contribution of genomic samples to Genomic Databank for Burkitt Lymphoma, created by the Foundation for Burkitt Lymphoma Research.

    Time frame: baseline through end of study

  4. Develop new therapeutic targets using molecular profiling

    DNA copy number alterations through Array comparative genomic hybridization, preparation of a Illumina genomic DNA library through methylated DNA immunoprecipitation, and DNA telomere length analysis.

    Time frame: after baseline, through end of study

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

    Determination as to whether the tumor-specific genetic aberrations from the human material can be used as biomarkers that correlate with disease-free survival by using the proprietary method, CAPP-Seq, for analyzing tumor genomic DNA in addition to tumor derived DNA analysis using Real-SeqS.

    Time frame: baseline through end of study

07

Study locations

1 of 2 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
  • University of the West Indies
    Kingston, Jamaica
    Terminated

    Not enrolling at this site.

08

References and documents

Publications

  • 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. PubMed 12075054 ↗
  • Lenz G, Staudt LM. Aggressive lymphomas. N Engl J Med. 2010 Apr 15;362(15):1417-29. doi: 10.1056/NEJMra0807082. PubMed 20393178 ↗
  • 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. PubMed 12975453 ↗

Individual participant data

Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT01676805
Responsible party
Sponsor
First posted
Aug 31, 2012
Start date
Sep 21, 2012
Last update
Oct 26, 2026

Study contacts

NCIMO Referral Office
Contact
ncimo_referrals@mail.nih.gov
(888) 624-1937
Christopher J Melani, M.D.
Contact
christopher.melani@nih.gov
(240) 760-6057
Christopher J Melani, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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