Studies genes of virus-linked cancers in people with HIV or immune disorders
Collects tissue and blood samples from adults with HIV, Castleman disease or related cancers.
Key facts
- Who runs it
- National Cancer Institute (NCI)
- Where
- Bethesda, United StatesSee the site
- Trial code
- Registry title
- Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease
- Status
- Recruiting
- People taking part
- 280 people, planned
- Started
- 20 Dec 2017
- Expected to end
- 25 Jun 2037
- Type of study
- Observational
- Record updated
- 16 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with certain cancers linked to a virus, to HIV or another immune problem, or with Castleman disease. Researchers study the genes in their tissue.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Cancer linked to HIV or another acquired immune problem, cancer linked to a virus, KSHV-linked cancer such as Multicentric Castleman Disease (MCD), cancer thought to be caused by an endogenous retrovirus, or idiopathic Castleman disease. HIV-negative people can join if their cancer is the kind that often occurs in people with HIV.
Main reasons for not taking part
- Cannot give informed consent
- Pregnant women cannot join
- ECOG performance status above 2 if the biopsy is done only for this trial
The registry criteria, word for word
Show all 12 criteriaShow less
Who cannot take part
- Inability to provide informed consent
- Pregnancy: Pregnant women will not be allowed to participate in this study because there is not a potential benefit
Other criteria
- 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
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesContact: Irene B Ekwede, R.N.Taking people
About the trial
What the trial wants to find out
Background:
Read full original descriptionShow less
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.
...
The group in the trial
- 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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease
- Plain-language title
- Studies genes of virus-linked cancers in people with HIV or immune disordersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Kaposi Sarcoma Herpesvirus (KSHV) Subtypes and Impact on Outcomes in KSHV-Associated Diseases.The Journal of infectious diseases, 2026
- Record updated
- 16 October 2026