Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease
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|ClinicalTrials.gov Identifier: NCT03300830|
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : July 22, 2019
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.
To study the biology of cancer in order to improve ways to prevent, detect, and treat it.
Adults at least 18 years old with certain cancers and/or immunodeficiencies
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.
|Condition or disease|
|Human Immunodeficiency Virus Castleman's Disease Kaposi's Sarcoma Viral-Associated Cancer|
- 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
-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.
- 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
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||230 participants|
|Official Title:||Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease|
|Actual Study Start Date :||December 20, 2017|
|Estimated Primary Completion Date :||June 7, 2037|
|Estimated Study Completion Date :||June 25, 2037|
Viral-assoc. cancer; HIV-neg pts with cancer that occurs in HIV pos; KSHV-assoc. cancer or related diseases e.g. multicentric Castleman disease; retrovirus-induced cancer; Idiopathic Castleman disease.
- Tissue collection [ Time Frame: Time of collection ]Molecular data from viral associated malignancies, malignancies occurring in the setting of HIV or other immunodeficiencies, and Castleman disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300830
|Contact: Irene Ekwede, R.N.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Robert Yarchoan, M.D.||National Cancer Institute (NCI)|