Assessment of Bone Mineral Density in People Living With HIV and KSHV Associated Malignancies: A Retrospective Longitudinal Analysis
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|ClinicalTrials.gov Identifier: NCT04742387|
Recruitment Status : Active, not recruiting
First Posted : February 8, 2021
Last Update Posted : July 4, 2022
Some people with human immunodeficiency virus (HIV) are on antiretroviral therapy (ART). Their cells have shown to age faster than expected. This puts them at higher risk for a range of age-related diseases about 10 years sooner than people who do not have HIV. Low bone mineral density (BMD) is common in people with HIV. This means their risk of fractures is increased. People with HIV also have a higher risk for cancers caused by Kaposi's sarcoma herpesvirus (KSHV) than people who do not have HIV. Much of the data on bone loss related to cancer and cancer treatments has been gathered from people who do not have HIV. Researchers want to learn more about the rate of bone loss in people with HIV/AIDS and KSHV associated cancers.
To learn the factors that are linked to BMD loss in people with HIV and KSHV associated cancers from imaging performed as part of NIH studies.
Adults with HIV and Kaposi s sarcoma who got ART and cancer chemotherapy at NIH from 1/1/2005 to 12/1/2020.
Participants' records will be chosen from studies that were conducted from 1/1/2005 to 12/1/2020. This study will include participants who had at least 2 CT scans. Some participants may have opted out of the future use of their data. If so, their records will not be used.
This study will use data collected at NIH. Data taken from CT scans will be used to measure BMD.
Study results may be published.
This study will last about 2 years.
|Condition or disease|
|Kaposi Sarcoma KSHV Associated Multicentric Castleman Disease Primary Effusion Lymphoma IL-6 Related KSHV Associated Cytokine Syndrome|
Assessment of Bone Mineral Density in People Living with HIV and KSHV Associated Malignancies: A Retrospective Longitudinal Analysis
This is a retrospective review that includes all participants with human immunodeficiency virus (HIV) (PWH) affected by Kaposi sarcoma (KS), KSHV-associated multicentric Castleman disease, and KSHV associated inflammatory cytokine syndrome enrolled on the tissue procurement study (01-C-0038) and other treatment protocols within the HIV/AIDS Malignancy Branch at the National Cancer Institute (NCI) from 1/1/2005 to 12/1/2020.
To determine the factors that are associated with bone mineral density (BMD) loss in PWH and KSHV associated malignancies.
All patients seen at the NIH from 1/1/2005 to 12/1/2020.
Description of Sites/Facilities conducting research:
This is a single site study initiated by the HIV/AIDS Malignancy Branch at the National Cancer Institute
Data abstraction to completion of data analyses will take about 2 years.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Assessment of Bone Mineral Density in People Living With HIV and KSHV Associated Malignancies: A Retrospective Longitudinal Analysis|
|Actual Study Start Date :||February 4, 2021|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Medical records of subjects enrolled on various studies conducted by HAMB/CCR from 1/1/2005 to 12/1/2020
- BMD loss [ Time Frame: ongoing ]To determine variables that are associated with BMD loss in participants with HIV and KSHV associated malignancies from retrospective imaging performed as part of clinical research protocols
- longitudinal change in BMD [ Time Frame: ongoing ]To estimate the longitudinal change in BMD from study baseline
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): NCT04742387
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Ramya M Ramaswami, M.D.||National Cancer Institute (NCI)|