Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease



Status:Recruiting
Conditions:Cancer, HIV / AIDS, Lymphoma
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - 99
Updated:12/21/2018
Start Date:December 20, 2017
End Date:June 25, 2037
Contact:Matthew R Lindsley, R.N.
Email:matthew.lindsley@nih.gov
Phone:(240) 760-6534

Use our guide to learn which trials are right for you!

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.

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 patients as well as patients 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 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.

- 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 less than or equal to 2 (Karnofsky greater than or equal to
.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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
301-496-2563
Phone: 888-624-1937
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials