ClinicalTrials.gov record NCT03300830

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 28, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationUnited States
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 tumor and non-tumor samples from adults with viral-associated cancers, cancers occurring with HIV or other immune disorders, and Castleman disease. Participants give medical history, have a physical exam and lab tests, and provide tissue samples; blood or urine may also be collected. Samples (including archival tissue or new biopsies when needed) will be analyzed to compare tumor and normal DNA, may be used to grow cells in the lab, and will be stored for future research. Participants may be contacted about results.

What it is studying. It aims to characterize the genes, mutations, and other molecular features of viral-associated malignancies, cancers occurring with HIV or other immunodeficiencies, tumors hypothesized to arise from endogenous retroviruses, and Castleman disease.

What the researchers hope to learn. To support molecular investigation by assembling clinically annotated tissue; to identify diagnostic or prognostic molecular signatures; to detect recurrent driver alterations and non-human sequences; and to find potential targets for future research and therapies.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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. ...

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.
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.

Participants will have a medical history review, a physical exam, and laboratory tests for screening. They may give tissue samples (the protocol states a biopsy will be collected if sufficient archival tissue is not available), and may give blood and urine; tissue removed during clinical surgery or other NIH protocols may also be used. Researchers may compare genes in tumor and non-tumor samples, may grow cells from your tissue in a laboratory, and will store samples for future research without personal identifiers; you may be contacted about results. The study team will also collect information from your medical records.

How the study is structured. A prospective observational cohort: researchers collect medical history, perform a physical exam and lab tests for screening, and obtain tumor and non-tumor samples (archival or new biopsy if archival tissue is insufficient). Blood or urine may also be collected. Samples are processed with project-specific protocols for genomic and molecular analyses, may be used to grow cells in the lab, and will be stored for future research.

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 Castleman disease

Clinical trials14 trials listed for Castleman diseaseEvery trial the registry lists for Castleman disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Castleman disease researchLatest monthly update: September 2026. Includes: Unicentric tumor removal. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Dec 20, 2017
Primary completion
Jun 7, 2037 (estimated)
Study completion
Jun 25, 2037 (estimated)
Target enrollment
280 participants (estimated)
Last updated on registry
Sep 28, 2026
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
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.

Participating sites (1)

  • National Institutes of Health Clinical CenterRecruiting

    Bethesda, Maryland, 20892 · United States

    • For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · 888-624-1937

Terms used on this page · explanations by MedicalUpdates.ai

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.
ECOG performance status
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
Karnofsky
A scale from 100 (no complaints) down to 0 that describes how well a person can carry out daily activities. Studies often require a minimum score.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
INCLUSION CRITERIA
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
EXCLUSION CRITERIA
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
natural history
A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
primary objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.

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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