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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-20

Study Completion Date

2037-06-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

...

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical, Laboratory and Epidemiologic Pilot Studies of Individuals at High Risk for Viral-Associated Cancers

NCT00001560

Acquired Immunodeficiency Syndrome Kaposi's Sarcoma Leukemia +3 more

COMPLETED

Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer

NCT00006518

HIV Kaposi's Sarcoma Lymphomas +2 more

RECRUITING

Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi

NCT03160183

Kaposi Sarcoma HIV

COMPLETED

Genetic Analysis of Brain Tumors

NCT00031538

Glioma Glioblastoma Multiforme Anaplastic Astrocytoma +2 more

TERMINATED

Genetic Analysis of Inherited Urologic Malignant Disorders: Collection of Samples

NCT00001814

Neoplastic Syndromes, Hereditary Urologic Neoplasms

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Immunodeficiency Virus Castleman's Disease Kaposi's Sarcoma Viral-Associated Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group 1

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No