Status:
RECRUITING
Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Human Immunodeficiency Virus
Castleman's Disease
Eligibility:
All Genders
18+ years
Brief 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 sequencin...
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, mal...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients 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 patients with cancer that commonly occurs in people with HIV
- -KSHV-associated malignancy or related diseases, such as Multicentric Castleman Disease
- A malignancy hypothesized to be caused by an endogenous retrovirus
- Idiopathic Castleman disease
- Cancer diagnoses will be confirmed by the NCI Laboratory of Pathology. 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 patient 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.
- Patients 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 patient 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.
Exclusion
Key Trial Info
Start Date :
December 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 25 2037
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT03300830
Start Date
December 20 2017
End Date
June 25 2037
Last Update
June 3 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892