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

  • STATUS
    Recruiting
  • End date
    Jun 25, 2037
  • participants needed
    230
  • sponsor
    National Cancer Institute (NCI)
Updated on 12 September 2021
cancer
immunodeficiency
HIV Vaccine

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.

...

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 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.

Details
Condition Castleman's Disease, HIV, HIV positive, HIV infection, AIDS Vaccines, Kaposi's Sarcoma, Retroviridae, Lymphoproliferative Disorder, human herpesvirus 8, HIV (Pediatric), Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, HIV Infections, Lymphoproliferative disorders, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, human immunodeficiency virus, hiv disease, kaposi sarcoma, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer, Viral-Associated Cancer
Clinical Study IdentifierNCT03300830
SponsorNational Cancer Institute (NCI)
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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