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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-C-0174

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women;
Fetuses;
Children

Keywords

Immunodeficiency;
Viral-Associated Cancer;
Kaposi Sarcoma Herpes Virus;
Idiopathic Castleman Disease;
Endogenous Retroviruses;
Natural History

Recruitment Keyword(s)

None

Condition(s)

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

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Robert Yarchoan, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 6N106
10 CENTER DR
BETHESDA MD 20892
(240) 760-6075
robert.yarchoan@nih.gov

Irene Ekwede, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 4N216
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6126
irene.ekwede@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT03300830

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