Status:
COMPLETED
Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America
Lead Sponsor:
AIDS Malignancy Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
The Emmes Company, LLC
Conditions:
HIV Infection
Human Immunodeficiency Virus 1 Positive
Eligibility:
All Genders
18+ years
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 Ameri...
Detailed Description
PRIMARY OBJECTIVES: I. 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 prev...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Participants not meeting all criteria above are ineligible.
Key Trial Info
Start Date :
January 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 18 2021
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT04089488
Start Date
January 17 2020
End Date
October 18 2021
Last Update
September 1 2023
Active Locations (4)
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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
Mexico City, Mexico, 14080