Exploring genetic factors in viral-associated tumors and immune disorders
Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease
This study is trying to find out how genetic factors in tumors linked to viral infections affect people with HIV, immune disorders, or Castleman disease, to help improve diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT03300830 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with HIV or other immunodeficiencies and cancer, viral-associated cancers, or Castleman disease.
Not a fit: Patients without any form of cancer or immunodeficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to better prevention, detection, and treatment options for patients with viral-associated cancers and immune disorders.
How similar studies have performed: Other studies have shown promise in understanding viral-associated malignancies, but this specific approach focusing on comprehensive genomic analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.