Exploring genetic factors in viral-associated tumors and immune disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the molecular characteristics of tumors associated with viral infections, particularly in patients with HIV or other immune disorders, as well as those with Castleman disease. Researchers will collect and analyze tissue, blood, and urine samples from participants to identify genetic variants that may influence cancer biology and treatment outcomes. The study focuses on understanding the interplay between viral factors and tumor development, which could lead to improved diagnostic and therapeutic strategies for affected individuals.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Robert Yarchoan, M.D. — National Cancer Institute (NCI)
• Study coordinator: Irene B Ekwede, R.N.
• Email: irene.ekwede@nih.gov
• Phone: (240) 760-6126

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.