Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease
2 other identifiers
observational
280
1 country
1
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. ...
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2017
CompletedFirst Posted
Study publicly available on registry
October 4, 2017
CompletedStudy Start
First participant enrolled
December 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2037
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 25, 2037
February 5, 2026
January 29, 2026
19.5 years
October 3, 2017
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tissue collection
Molecular data from viral associated malignancies, malignancies occurring in the setting of HIV or other immunodeficiencies, and Castleman disease
Time of collection
Study Arms (1)
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 (MCD); retrovirus-induced cancer; Idiopathic Castleman disease
Eligibility Criteria
The study population will be participants referred by HIV providers and those who provide primary care to the African immigrant community.
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (1)
Ramaswami R, Tagawa T, Mahesh G, Serquina A, Koparde V, Lurain K, Dremel S, Li X, Mungale A, Beran A, Ohler ZW, Bassel L, Warner A, Mangusan R, Widell A, Ekwede I, Krug LT, Uldrick TS, Yarchoan R, Ziegelbauer JM. Transcriptional landscape of Kaposi sarcoma tumors identifies unique immunologic signatures and key determinants of angiogenesis. J Transl Med. 2023 Sep 22;21(1):653. doi: 10.1186/s12967-023-04517-5.
PMID: 37740179DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Yarchoan, M.D.
National Cancer Institute (NCI)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2017
First Posted
October 4, 2017
Study Start
December 20, 2017
Primary Completion (Estimated)
June 7, 2037
Study Completion (Estimated)
June 25, 2037
Last Updated
February 5, 2026
Record last verified: 2026-01-29
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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
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.