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 |
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Recruitment Status :
Recruiting
First Posted : October 4, 2017
Last Update Posted : January 25, 2023
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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.
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| Condition or disease |
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| Human Immunodeficiency Virus Castleman's Disease Kaposi's Sarcoma Viral-Associated Cancer |
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, , 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.
| Study Type : | Observational |
| Estimated Enrollment : | 230 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Group/Cohort |
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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
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- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- 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.
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) 760-6126 | ekwedeib@mail.nih.gov | |
| Contact: Robert Yarchoan, M.D. | (240) 760-6075 | robert.yarchoan@nih.gov |
| 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) |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT03300830 |
| Other Study ID Numbers: |
170174 17-C-0174 |
| First Posted: | October 4, 2017 Key Record Dates |
| Last Update Posted: | January 25, 2023 |
| Last Verified: | January 20, 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | .All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Time Frame: | Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active. |
| Access Criteria: | Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Immunodeficiency Viral-Associated Cancer Kaposi Sarcoma Herpes Virus |
Idiopathic Castleman Disease Endogenous Retroviruses Natural History |
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Acquired Immunodeficiency Syndrome HIV Infections Sarcoma, Kaposi Sarcoma Castleman Disease Immunologic Deficiency Syndromes Immune System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Blood-Borne Infections Communicable Diseases Infections |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Slow Virus Diseases Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |