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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04742387
Recruitment Status : Active, not recruiting
First Posted : February 8, 2021
Last Update Posted : July 4, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief 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. 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.


Condition or disease
Kaposi Sarcoma KSHV Associated Multicentric Castleman Disease Primary Effusion Lymphoma IL-6 Related KSHV Associated Cytokine Syndrome

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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
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


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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. longitudinal change in BMD [ Time Frame: ongoing ]
    To estimate the longitudinal change in BMD from study baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary clinical
Criteria
  • 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.


Information from the National Library of Medicine

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


Locations
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United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ramya M Ramaswami, M.D. National Cancer Institute (NCI)
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04742387    
Other Study ID Numbers: 10000265
000265-C
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: July 4, 2022
Last Verified: December 30, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
AIDS
Antiretroviral Therapy
OSTEOPENIA
bone turnover markers
Natural History
Additional relevant MeSH terms:
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Sarcoma, Kaposi
Lymphoma, Primary Effusion
Castleman Disease
Neoplasms
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Neoplasms, Vascular Tissue
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma