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

Brief Title

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

Official Title

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

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.
    

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


Primary Outcome

BMD loss

Secondary Outcome

 longitudinal change in BMD

Condition

Kaposi Sarcoma


Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

40

Start Date

February 4, 2021

Completion Date

December 31, 2023

Primary Completion Date

June 30, 2023

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ramya M Ramaswami, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04742387

Organization ID

10000265

Secondary IDs

000265-C

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

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


Verification Date

July 28, 2021