Kaposi SarcomaNCT04742387
Assessment of Bone Mineral Density in People Living With HIV and KSHV Associated Malignancies: A Retrospective Longitudinal Analysis
An observational study of Kaposi Sarcoma and KSHV Associated Multicentric Castleman Disease, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kaposi Sarcoma, KSHV Associated Multicentric Castleman Disease, Primary Effusion Lymphoma
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2021to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary clinical
- STUDY POPULATION:
Subjects will not be recruited for this study; however, participants' records will be selected from treatment protocols from 1/1/2005 to 12/1/2020 unless the subject opted out of the future use of his/her data. These subjects enrolled to natural history and/or treatment protocols within the HIV/AIDS Malignancy Branch on the basis of a diagnosis of HIV and KSHV-associated conditions, such as KS alone, in combination with KSHV-MCD or KICS.
As this is a retrospective longitudinal study, the investigators will review the data from subjects who have at least two completed CT scans to measure bone mineral density.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Background:
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.
Read more
Objective:
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.
Eligibility:
Adults with HIV and Kaposi s sarcoma who got ART and cancer chemotherapy at NIH from 1/1/2005 to 12/1/2020.
Design:
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.
Read the detailed description
Title:
Assessment of Bone Mineral Density in People Living with HIV and KSHV Associated Malignancies: A Retrospective Longitudinal Analysis
Study Description:
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.
Objectives:
To determine the factors that are associated with bone mineral density (BMD) loss in PWH and KSHV associated malignancies.
Study Population:
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
Study Duration:
Data abstraction to completion of data analyses will take about 2 years.
- Conditions
- Kaposi Sarcoma, KSHV Associated Multicentric Castleman Disease, Primary Effusion Lymphoma, IL-6 Related KSHV Associated Cytokine Syndrome
- Keywords
- AIDS, Antiretroviral Therapy, OSTEOPENIA, bone turnover markers, Natural History
- Medical subject headings
- Sarcoma, Kaposi, Multi-centric Castleman's Disease, Lymphoma, Primary Effusion, Acquired Immunodeficiency Syndrome, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Medical records of subjects enrolled on various studies conducted by HAMB/CCR from 1/1/2005 to 12/1/2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD loss
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
Measured: ongoing
Secondary outcomes (1)
longitudinal change in BMD
To estimate the longitudinal change in BMD from study baseline
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start4 Feb 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kaposi SarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ramya M Ramaswami, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742387
- Sponsor's protocol ID
- 10000265
- Other IDs
- 000265-C
- Status last verified
- 21 Aug 2026
- First submitted
- 5 Feb 2021
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No