Clinical trial NCT03300830: Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease
Official title: Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Immunodeficiency Virus
Castleman's Disease
Kaposi's Sarcoma
Viral-Associated Cancer
Keywords: Immunodeficiency
Viral-Associated Cancer
Kaposi Sarcoma Herpes Virus
Idiopathic Castleman Disease
Endogenous Retroviruses
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2017-10-04
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be patients referred by HIV providers and those who provide primary care to the African immigrant community.

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 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.

...

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, malignancies occurring in the setting of 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 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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Tissue collection
timeFrame: Time of collection
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Robert Yarchoan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: