NCT04089488

Brief Summary

This trial studies the frequency of incident and prevalent of cancer in people living with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) at cancer centers in Latin America. By counting how many people living with HIV/AIDS have cancer at these specific centers, researchers may better understand how they are being treated and cared for. This may help researchers to understand what new studies may be helpful for those areas in the future.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 17, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2021

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 22, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

September 12, 2019

Results QC Date

June 1, 2023

Last Update Submit

August 21, 2023

Conditions

HIV InfectionHuman Immunodeficiency Virus 1 PositiveMalignant NeoplasmRecurrent Malignant Neoplasm

Outcome Measures

Primary Outcomes (5)

  • Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites

    The primary endpoint will be the estimates of site-specific frequency of new diagnosis and existing cases (recurrence and surveillance) presenting with HIV and cancer presenting over 1 year, 9 months (21 months) at the clinical sites.

    Up to 21 months

  • Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.

    The mean cases per month of incidence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the study site.

    21 months

  • Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type.

    The mean cases per month of incidence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the cancer type.

    21 months

  • Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.

    The mean cases per month of prevalence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the study site.

    21 months

  • Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type

    The mean cases per month of prevalence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the cancer type.

    21 months

Secondary Outcomes (5)

  • Information on the Use of Diagnostic Testing in HIV-positive Individuals

    Up to 21 months

  • HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer

    Up to 21 months

  • Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals

    Up to 21 months

  • CD4 of HIV-positive Individuals Diagnosed With Cancer

    Baseline

  • HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer

    Baseline

Study Arms (1)

Observational (respond to surveys, medical record review)

Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.

Other: Medical Chart ReviewOther: Survey Administration

Interventions

Medical Chart ReviewOTHER

Correlative studies

Also known as: Chart Review
Observational (respond to surveys, medical record review)
Survey AdministrationOTHER

Respond to surveys

Observational (respond to surveys, medical record review)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants presenting to HIV treatment programs or cancer treatment programs at collaborating sites, with both HIV and cancer, which may include either a history of malignancy or current diagnosis

You may qualify if:

  • HIV positive. Documentation of HIV-1 infection by means of any one of the following:
  • Documentation of receipt of ART by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name);
  • HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \> 1000 RNA copies/mL, and confirmed by a licensed screening antibody and/or HIV antibody/antigen combination assay;
  • Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay, such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.
  • Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally.
  • WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/Custom Industrial Analysis (CIA) that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.
  • Must have a current or prior (within the last 5 years) diagnosis of cancer, but there is no restriction of the number or type of prior treatments. Participants will qualify under one of three categories:
  • New diagnosis: no prior treatment for current malignancy. May be prior to, or currently receiving the first line of therapy.
  • Prior diagnosis (within 5 years), in remission: Not currently on cancer treatment other than combination antiretroviral therapy (cART). Prior treatment for malignancy can include surgery, radiation, or chemotherapy (or cART initiation in Kaposi sarcoma \[KS\]). No restriction on number of prior lines of therapy.
  • Prior diagnosis, recurrent: considering or currently receiving treatment that is not first line. No restriction on the number of prior lines of therapy.
  • Date of birth and age should be determined based on best possible information or documentation available.
  • Ability to understand and the willingness to provide informed consent document.

You may not qualify if:

  • Participants not meeting all criteria above are ineligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital de Agudos Juan A. Fernandez

Buenos Aires, Argentina

Location

Instituto Nacional de Câncer José de Alencar

Rio de Janeiro, 20231-050, Brazil

Location

Complexo Hospitalar Universitário Professor Edgard Santos

Salvador, Brazil

Location

Instituto Nacional de Cancerologia

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

HIV InfectionsNeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Deukwoo Kwon
Organization
Statistical and Data Analysis Center, AIDS Malignancy Consortium
deukwoo.kwon@mountsinai.org
(713) 500-7964

Study Officials

  • Robert M Strother

    AIDS Malignancy Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2019

First Posted

September 13, 2019

Study Start

January 17, 2020

Primary Completion

October 18, 2021

Study Completion

October 18, 2021

Last Updated

September 1, 2023

Results First Posted

August 22, 2023

Record last verified: 2023-08

Locations

ME(1)BR(2)AR(1)