- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04089488
Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America
Prospective Observational Study of Site-Specific Incident and Prevalent Cases of Cancer in People Living With HIV/AIDS- in Latin America
Study Overview
Status
Conditions
Intervention / Treatment
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 prevalence based on all presenting cancers (new diagnosis, recurrence, and surveillance cases) and site-specific incidence based on newly diagnosed cancers.
SECONDARY OBJECTIVES:
I. Obtain information on the use of diagnostic testing and treatment for the cohort of diagnosed HIV-associated cancer participants.
II. To collect information on participant characteristics for diagnosed HIV-associated cancers (e.g., antiretroviral therapy [ART] regimen, current CD4 count, current viral load, etc.).
OUTLINE:
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
- Hospital de Agudos Juan A. Fernandez
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Rio De Janeiro, Brazil, 20231-050
- Instituto Nacional de Câncer José de Alencar
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Salvador, Brazil
- Complexo Hospitalar Universitário Professor Edgard Santos
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Ciudad de Mexico, Mexico, 14080
- Instituto Nacional de Cancerologia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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 Criteria:
- Participants not meeting all criteria above are ineligible.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Observational (respond to surveys, medical record review)
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.
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Correlative studies
Other Names:
Respond to surveys
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Up to 21 months
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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.
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Up to 21 months
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Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Time Frame: 21 months
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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
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Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type.
Time Frame: 21 months
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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
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Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Time Frame: 21 months
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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
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Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type
Time Frame: 21 months
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Information on the Use of Diagnostic Testing in HIV-positive Individuals
Time Frame: Up to 21 months
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The frequency of diagnostic testing modalities will be summarized for cancer.
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Up to 21 months
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HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Time Frame: Up to 21 months
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For each cancer, summary statistics will be used to describe the HIV treatment regimens and disease characteristics.
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Up to 21 months
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Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals
Time Frame: Up to 21 months
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The frequency of the Treatment for Cancers Diagnosed in HIV-positive Individuals will be summarized.
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Up to 21 months
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CD4 of HIV-positive Individuals Diagnosed With Cancer
Time Frame: Baseline
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CD4 percent of HIV-positive Individuals Diagnosed With Cancer will be summarized.
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Baseline
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HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer
Time Frame: Baseline
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HIV viral load of HIV-positive Individuals Diagnosed With Cancer will be summarized
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Baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Timelines and requirements for protocol review and approval at the local, regional, and national level
Time Frame: Up to 9 months
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For each site, the regulatory timelines and requirements will be described
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Up to 9 months
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Familiarization of local sites with the on-line data entry system utilized by the acquired immunodeficiency syndrome (AIDS) Malignancy Consortium (AMC)
Time Frame: Up to 9 months
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Familiarization will be assessed based upon data quality metrics defined by the site performance SOP
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Up to 9 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert M Strother, AIDS Malignancy Consortium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- Neoplasms
- HIV Infections
- Recurrence
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- AMC-S008 (Other Identifier: CTEP)
- UM1CA121947 (U.S. NIH Grant/Contract)
- NCI-2019-01734 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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