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RecruitingNCT03300830Updated Sep 22, 2026

Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease

An observational study in Human Immunodeficiency Virus, Castleman's Disease and Kaposi's Sarcoma, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
280
Ages
18 Years and older
Sex
All
01

Study summary

Background:

A person s genome is the collection of all their genes. A gene instructs individual cells to make proteins. Proteins are involved in all of our body s chemical processes. Genome sequencing allows researchers to find variations in genes. Some of these are normal and are not known to cause disease. Some variants are known to cause or affect diseases like cancer. Researchers want to study genetic variants in people with cancer who also have an immunologic disease like HIV.

Objective:

To study the biology of cancer in order to improve ways to prevent, detect, and treat it.

Eligibility:

Adults at least 18 years old with certain cancers and/or immunodeficiencies

Design:

Participants will be screened with medical history, physical exam, and lab tests.

Participants will give samples of one or more tissue type.

They may give blood or urine samples.

Researchers may get samples of tissue when participants have surgery or when the participants are on other protocols in the NCI.

Participants may have a procedure to have tissue samples removed.

Researchers may collect data from participant medical records.

Researchers will compare the genes in a participant s cancer tissue to their normal tissue. They may use the tissue cells to grow new cells in a lab.

Participants may be contacted about the results.

The samples will be stored for future research. No personal data will be kept with them.

Read the detailed description

Background:

  • The availability of high quality, clinically annotated patient samples is crucial for the study of biologic factors that influence the natural history of viral related malignancies, malignancies occurring in the setting of human immunodeficiency virus (HIV), and Castleman disease.
  • Comprehensive genomic sequence of viral-associated malignancies, malignancies occurring in the setting of HIV, tumors hypothesized to be caused by endogenous retroviruses, and Castleman disease may identify diagnostic or prognostic disease signatures, and recurrent driver alterations that interact with viral factors, and may identify targets for new therapies.
  • Comparison of transcriptomes and genomes between cancers or Castleman disease from HIV+ and HIV- individuals might identify novel non-human sequences that could potentially suggest the presence of transcripts from hitherto undiscovered oncogenic viral agents.

Objective:

-The primary objective of this protocol is to support molecular investigation of viral associated malignancies, malignancies occurring in the setting of HIV or other immunodeficiencies, and Castleman disease, by accrual of high quality, clinically annotated tissue from such participants as well as participants with tumors that may serve as appropriate controls.

Eligibility:

  • Age >=18 years
  • HIV or other acquired immunodeficiency and cancer or
  • Viral-associated cancer or
  • HIV-negative with cancer that commonly occurs in people with HIV or
  • Kaposi sarcoma herpes virus (KSHV)-associated malignancy or related diseases, such as Multicentric Castleman Disease (MCD) or
  • Idiopathic Castleman disease or
  • Tumors that are hypothesized to be caused by endogenous retroviruses

Design:

  • Samples will be processed using project specific collection and processing protocols.
  • Collection of non-tumor specimens will generally be performed to obtain germ-line genetic material. The results between tumor and normal DNA will be analyzed to identify the somatic changes present in the cancer tissues.
  • Alterations to be evaluated may include: detection of chromosomal changes, such as, but not limited to, amplification, deletions, loss of heterozygosity, translocations, etc.; as well as expression profiling and detection of transcripts resulting from translocations and mutations, including single nucleotide variants, insertions, deletions, etc.
  • Multiple forms of project specific analyses may be performed, including evaluation of polymorphisms, mutations, gene expression, circulatory and tissue-based biomarkers, whole exome sequencing, and clinical pathologic correlation based on project specific statistical and bioinformatics plans.
  • Alterations may also be analyzed within the context of biological pathways and systems biology being evaluated in a given project.
02

Conditions studied

  • Human Immunodeficiency Virus
  • Castleman's Disease
  • Kaposi's Sarcoma
  • Viral-Associated Cancer

Keywords

  • Immunodeficiency
  • Viral-Associated Cancer
  • Kaposi Sarcoma Herpes Virus
  • Idiopathic Castleman Disease
  • Endogenous Retroviruses
  • Natural History
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will be participants referred by HIV providers and those who provide primary care to the African immigrant community.

Inclusion criteria

Participants with one or more of the following:

  • HIV or other acquired immunodeficiency and cancer
  • Viral-associated cancer or cancer hypothesized to be caused by a virus
  • HIV-negative participants with cancer that commonly occurs in people with HIV

    --KSHV-associated malignancy or related diseases, such as Multicentric Castleman Disease (MCD)

  • A malignancy hypothesized to be caused by an endogenous retrovirus
  • Idiopathic Castleman disease

Cancer diagnoses will be confirmed by the NCI Laboratory of Pathology (LP). A biopsy will be collected if sufficient archival tissue is not available.

  • Age >=18 years.
  • ECOG performance status \<=2 (Karnofsky >=60%) if biopsy to be performed is solely for the purposes of this protocol. Any ECOG performance status will be allowed if biopsy required for participant care or another NIH protocol that allows lower performance status or if enrollment on this protocol is only for the purposes of studying tissue that has already been collected.
  • Participants must have signed or be willing to sign an IRB-approved informed consent document that permits the use of the tumor and other samples for genomic-based molecular characterization projects. Telephone consent for use of archival tissue or tissue collected on another protocol or standard participant care will be permitted.
  • Co-enrollment on other HAMB, NCI, or NIH protocols is allowed

Exclusion criteria

EXCLUSION CRITERIA:

  • Inability to provide informed consent.
  • Pregnancy: Pregnant women will not be allowed to participate in this study because there is not a potential benefit.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
280 participants (estimated)

Groups and cohorts

  • group 1

    Viral-assoc. cancer; HIV-neg pts with cancer that occurs in HIV pos; KSHV-assoc. cancer or related diseases e.g. multicentric Castleman disease (MCD); retrovirus-induced cancer; Idiopathic Castleman disease

05

What researchers measure

Primary outcomes

  1. Tissue collection

    Molecular data from viral associated malignancies, malignancies occurring in the setting of HIV or other immunodeficiencies, and Castleman disease

    Time frame: Time of collection

06

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    • For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · Contact · 888-624-1937
    Recruiting
07

References and documents

Publications

  • Ramaswami R, Tagawa T, Mahesh G, Serquina A, Koparde V, Lurain K, Dremel S, Li X, Mungale A, Beran A, Ohler ZW, Bassel L, Warner A, Mangusan R, Widell A, Ekwede I, Krug LT, Uldrick TS, Yarchoan R, Ziegelbauer JM. Transcriptional landscape of Kaposi sarcoma tumors identifies unique immunologic signatures and key determinants of angiogenesis. J Transl Med. 2023 Sep 22;21(1):653. doi: 10.1186/s12967-023-04517-5. PubMed 37740179 ↗

Individual participant data

Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Supporting information: Study protocol, Sap, Icf

08

Registry details

Key details

Study ID
NCT03300830
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 4, 2017
Start date
Dec 20, 2017
Primary completion
Jun 7, 2037 (estimated)
Completion
Jun 25, 2037 (estimated)
Last update
Sep 22, 2026

Study contacts

Irene B Ekwede, R.N.
Contact
irene.ekwede@nih.gov
(240) 760-6126
Robert Yarchoan, M.D.
Contact
robert.yarchoan@nih.gov
(240) 760-6075
Robert Yarchoan, 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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