Assessment of Bone Mineral Density in People Living With HIV and KSHV Associated Malignancies: A Retrospective Longitudinal Analysis

January 12, 2024 updated by: National Cancer Institute (NCI)

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

primary clinical

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
1
Medical records of subjects enrolled on various studies conducted by HAMB/CCR from 1/1/2005 to 12/1/2020

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
ongoing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
longitudinal change in BMD
Time Frame: ongoing
To estimate the longitudinal change in BMD from study baseline
ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ramya M Ramaswami, M.D., National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

September 28, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10000265
  • 000265-C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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