NCT03300830 Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease
| NCT ID | NCT03300830 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Human Immunodeficiency Virus |
| Study Type | OBSERVATIONAL |
| Enrollment | 280 participants |
| Start Date | 2017-12-20 |
| Primary Completion | 2037-06-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 280 participants in total. It began in 2017-12-20 with a primary completion date of 2037-06-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. ...
Eligibility Criteria
* INCLUSION CRITERIA: Participants 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 participants with cancer that commonly occurs in people with HIV --KSHV-associated malignancy or related diseases, such as Multicentric Castleman Disease (MCD) * A malignancy hypothesized to be caused by an endogenous retrovirus * Idiopathic Castleman disease Cancer diagnoses will be confirmed by the NCI Laboratory of Pathology (LP). 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 participant 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. * Participants 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 participant 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.
Contact & Investigator
Robert Yarchoan, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT03300830 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Human Immunodeficiency Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03300830 currently recruiting?
Yes, NCT03300830 is actively recruiting participants. Contact the research team at irene.ekwede@nih.gov for enrollment information.
Where is the NCT03300830 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT03300830 clinical trial?
NCT03300830 is sponsored by National Cancer Institute (NCI). The principal investigator is Robert Yarchoan, M.D. at National Cancer Institute (NCI). The trial plans to enroll 280 participants.