Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
PRIMARY OBJECTIVES:
- To determine the number of diagnosed cancers in people living with HIV/AIDS (PLWHA) presenting to participating clinical sites in Latin America, and estimate site-specific prevalence based on all presenting cancers (new diagnosis, recurrence, and surveillance cases) and site-specific incidence based on newly diagnosed cancers.
SECONDARY OBJECTIVES:
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Obtain information on the use of diagnostic testing and treatment for the cohort of diagnosed HIV-associated cancer participants.
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To collect information on participant characteristics for diagnosed HIV-associated cancers (e.g., antiretroviral therapy [ART] regimen, current CD4 count, current viral load, etc.).
EXPLORATORY OBJECTIVES:
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To determine the timelines and requirements for protocol review and approval at the local, regional, and national level.
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To familiarize local sites with the online data entry systems utilized by the AIDS Malignancy Consortium (AMC).
OUTLINE:
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Review
Correlative studies
Other Names:
Other: Survey Administration
Respond to surveys
|
Outcome Measures
Primary Outcome Measures
- 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 [Up to 9 months]
For each geographic site and type of cancer, the number of incident and prevalent cases will be estimated using a 95% Poisson confidence interval.
Secondary Outcome Measures
- Information on the use of diagnostic testing and treatment for cancers diagnosed in HIV-positive individuals [Up to 9 months]
The frequency of diagnostic testing modalities and cancer treatment regimens will be summarized for cancer.
- HIV treatment and disease characteristics of HIV-positive individuals diagnosed with cancer [Up to 9 months]
For each cancer, summary statistics will be used to describe the HIV treatment regimens and disease characteristics.
Other Outcome Measures
- Timelines and requirements for protocol review and approval at the local, regional, and national level [Up to 9 months]
For each site, the regulatory timelines and requirements will be described
- Familiarization of local sites with the on-line data entry system utilized by the acquired immunodeficiency syndrome (AIDS) Malignancy Consortium (AMC) [Up to 9 months]
Familiarization will be assessed based upon data quality metrics defined by the site performance SOP
Eligibility Criteria
Criteria
Inclusion Criteria:
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HIV positive. Documentation of HIV-1 infection by means of any one of the following:
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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);
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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;
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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.
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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.
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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.
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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:
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New diagnosis: no prior treatment for current malignancy. May be prior to, or currently receiving the first line of therapy.
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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.
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Prior diagnosis, recurrent: considering or currently receiving treatment that is not first line. No restriction on the number of prior lines of therapy.
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Date of birth and age should be determined based on best possible information or documentation available.
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Ability to understand and the willingness to provide informed consent document.
Exclusion Criteria:
- Participants not meeting all criteria above are ineligible.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital de Agudos Juan A. Fernandez | Buenos Aires | Argentina | ||
| 2 | Instituto Nacional de Câncer José de Alencar | Rio De Janeiro | Brazil | 20231-050 | |
| 3 | Complexo Hospitalar Universitário Professor Edgard Santos | Salvador | Brazil | ||
| 4 | Instituto Nacional de Cancerologia | Ciudad de Mexico | Mexico | 14080 |
Sponsors and Collaborators
- AIDS Malignancy Consortium
- National Cancer Institute (NCI)
- The Emmes Company, LLC
- University of Arkansas
Investigators
- Principal Investigator: Robert M Strother, AIDS Malignancy Consortium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AMC-S008
- NCI-2019-01734
- AMC-S008
- AMC-S008
- UM1CA121947